NSCLC (Non-small Cell Lung Cancer)

53

Review clinical trials related to NSCLC (Non-small Cell Lung Cancer). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors

This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors

Participants needed: 738
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: NextCure, Inc.Updated: Aug 17, 2026Locations: 17
Eligibility criteria

Written informed consent is obtained prior to any procedures that are not consid... [+22]

For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors cont... [+23]

Status: Recruiting

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.

Participants needed: 201
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Yuhan CorporationUpdated: Aug 17, 2026Locations: 8
Eligibility criteria

ECOG performance status 0 or 1 [+13]

Patient with symptomatic or progressive brain metastases [+13]

Status: Recruiting

A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have: * a solid tumor which is metastatic or recurrent (excluding colorectal cancer) * tumor with the mutation (abnormal gene) called "BRAF V600" * received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.

Participants needed: 124
Trial details
Phase: Phase 1Age: 16+Biological sex: AllType: InterventionalSponsor: PfizerUpdated: Aug 14, 2026Locations: 83
Eligibility criteria

Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) [+4]

Other active malignancy within 3 years [+5]

Status: Recruiting

Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors

An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors

Participants needed: 12
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Rigel PharmaceuticalsUpdated: Aug 10, 2026Locations: 2
Eligibility criteria

Must be willing and able to participate and comply with all study requirements a... [+17]

Clinically relevant abnormal medical history, abnormal findings on physical exam... [+28]

Status: Recruiting

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

Participants needed: 300
Trial details
Phase: Phase 1, Phase 2Age: 12+Biological sex: AllType: InterventionalSponsor: PMV Pharmaceuticals, IncUpdated: Aug 10, 2026Locations: 77
Eligibility criteria

At least 18 years of age or 12 to 17 years of age after Safety Review Committee... [+7]

Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug [+22]

Status: Recruiting

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.

Participants needed: 366
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Marengo Therapeutics, Inc.Updated: Aug 11, 2026Locations: 19
Eligibility criteria

Participants must have histologically confirmed solid tumors that are unresectab... [+14]

Vitiligo; [+19]

Status: Recruiting

Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC

his multicenter, open-label, single-arm phase I/II trial will evaluate the safety, tolerability, and preliminary efficacy of oral paclitaxel solution combined with an immune checkpoint inhibitor and concurrent stereotactic body radiotherapy (SBRT) as neoadjuvant therapy in patients aged 70 years or older with resectable stage IIA-IIIB non-small cell lung cancer (NSCLC) without sensitizing EGFR, ALK, or ROS1 alterations. In Phase I, a 3+3 dose-escalation design will evaluate oral paclitaxel at 80, 120, and 160 mg/m² administered orally on Days 1 and 8 of each cycle, divided into morning and evening doses, in combination with an investigator-selected anti-PD-1 or anti-PD-L1 monoclonal antibody and SBRT at 8 Gy in 3 fractions. Phase II will expand enrollment at the recommended Phase II dose (RP2D). The principal efficacy outcome is pathologic complete response after surgery. Other outcomes include major pathologic response, radiographic response, event-free survival, overall survival, surgical resection and R0 resection rates, and exploratory biomarker changes.

Participants needed: 78
Trial details
Phase: Phase 4Age: 70+Biological sex: AllType: InterventionalSponsor: Shanghai Pulmonary Hospital, Shanghai, ChinaUpdated: Aug 10, 2026Locations: 5
Eligibility criteria

Age 70 years or older, regardless of sex. [+13]

Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy. [+9]

Status: Recruiting

A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation

The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC). GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC. This is an open-label, randomized controlled trial. Both participant and study doctor will know which study medication each participant receives. After enrollment, participant will be randomly assigned to either the GFH375 group or docetaxel group by chance. Neither participant nor study doctor can pick your treatment group. You have a two-thirds chance to receive GFH375 and a one-third chance to receive docetaxel. * GFH375 group: Take GFH375 tablets by mouth once daily as scheduled; each treatment cycle lasts 21 days. * Docetaxel group: Receive docetaxel via intravenous infusion at 75 mg/m² once every 3 weeks. Study treatment will continue until cancer gets worse, participant can't tolerate the study treatment, or other conditions make participant unable to keep receiving study treatment. Some participants on docetaxel may be able to switch to GFH375 during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and participant 's wellbeing throughout the study. Participants will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After participant's cancer becomes worse, clinic staff will telephone participant every 3 mouths to check on their cancer.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Genfleet Therapeutics (Shanghai) Inc.Updated: Aug 10, 2026Locations: 1
Eligibility criteria

1. Voluntary participation in the study and signed informed consent form (ICF). [+8]

1. Presence of other driver gene mutations in NSCLC, or concurrent other KRAS or... [+14]

Status: Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Participants needed: 590
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Revolution Medicines, Inc.Updated: Aug 6, 2026Locations: 152
Eligibility criteria

At least 18 years old and has provided informed consent. [+7]

Prior therapy with direct RAS-targeted therapy or docetaxel. [+4]

Status: Not yet recruiting

A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.

This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced/metastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)/Deficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.

Participants needed: 920
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Natera, Inc.Updated: Aug 4, 2026
Eligibility criteria

Signed Informed consent [+22]

Available alternate treatment options with curative intent, e.g. surgery and / o... [+12]

Status: Recruiting

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC

The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.

Participants needed: 160
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Peng ZhangUpdated: Aug 3, 2026Locations: 1
Eligibility criteria

NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy; [+9]

The patient has undergone any systemic anti-cancer treatment for NSCLC, includin... [+9]

Status: Recruiting

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.

Participants needed: 140
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Nuvectis Pharma, Inc.Updated: Jul 9, 2026Locations: 15
Eligibility criteria

Provide written informed consent. [+4]

Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpress... [+25]

Status: Recruiting

A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC

A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.

Participants needed: 110
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: EpiBiologicsUpdated: Jul 6, 2026Locations: 6
Eligibility criteria

Participant has a life expectancy > 12 weeks at Day 1. [+4]

Participant has history of uncontrolled illness. [+2]

Status: Recruiting

Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC

This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.

Participants needed: 160
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Males or females aged 18 to 75 years or older; [+15]

Concurrent enrolment in another clinical study, unless it is an observational(no... [+10]

Status: Recruiting

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)

This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: ElephasUpdated: Jun 29, 2026Locations: 8
Eligibility criteria

Able and willing to provide informed consent for participation [+3]

Have a known auto-immune disease or prior condition (prior organ transplant, chr... [+2]

Status: Not yet recruiting

Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade

This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy. This trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application. There is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy. The idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.

Participants needed: 12
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Weill Medical College of Cornell UniversityUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Age ≥18 years. [+6]

Previous exposure to immune checkpoint blockade. [+11]

Status: Recruiting

Study of XB010 in Subjects With Solid Tumors

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Participants needed: 396
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: ExelixisUpdated: Jun 22, 2026Locations: 20
Eligibility criteria

Age 18 years or older on the day of consent. [+5]

Status: Recruiting

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

Participants needed: 448
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Alterome Therapeutics, Inc.Updated: Jun 10, 2026Locations: 12
Eligibility criteria

Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS... [+4]

Prior treatment with a KRAS inhibitor, certain exceptions are described in the f... [+1]

Status: Recruiting

A Phase 1/1b Study of IAM1363 in HER2 Cancers

This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.

Participants needed: 383
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Iambic Therapeutics, IncUpdated: Jun 4, 2026Locations: 53
Eligibility criteria

Age ≥ 18 years [+7]

Clinically significant cardiac disease [+8]

Status: Recruiting

Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas

This is a phase 1/2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas.

Participants needed: 41
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: OSE ImmunotherapeuticsUpdated: Jun 4, 2026Locations: 11
Eligibility criteria

Signed and dated informed consent form (ICF) prior to any trialspecific procedur... [+19]

Status: Recruiting

Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%

This prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in May 2026, and recruitment is expected to conclude around May 2026, with the trial anticipated to end by May 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Participants needed: 60
Trial details
Phase: Phase 2Age: 65+Biological sex: AllType: InterventionalSponsor: Tang-Du HospitalUpdated: May 19, 2026Locations: 1
Eligibility criteria

1.Voluntary participation and informed consent: Subjects must voluntarily join t... [+6]

1. Hypersensitivity: Known hypersensitivity to serplulimab or any of its excipie...

Status: Recruiting

Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure

The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy. Participants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments: 1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W) 2. Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles 3. Microwave ablation, administered per protocol

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Cancer Institute and HospitalUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Patients with cytologically or histologically confirmed non-small cell lung canc... [+5]

Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-s... [+10]

Status: Recruiting

Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)

The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are: * Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment? * What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants. Participants will: * Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles). * Undergo surgical resection within 4 weeks after completing neoadjuvant therapy. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years). * Be monitored for adverse events and survival outcomes.

Participants needed: 20
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Tang-Du HospitalUpdated: Apr 1, 2026Locations: 1
Eligibility criteria

Provide informed consent prior to any study-specific procedures. [+17]

Presence of squamous cell carcinoma, large cell neuroendocrine carcinoma, or sma... [+12]

Status: Recruiting

177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Participants needed: 61
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Radiopharm Theranostics, LtdUpdated: Mar 27, 2026Locations: 4
Eligibility criteria

Willing and able to provide informed consent prior to start of any study procedu... [+2]

Participants must have documented disease progression during or after their most... [+44]

Status: Not yet recruiting

Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC

This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.

Participants needed: 38
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Cancer Institute and HospitalUpdated: Mar 27, 2026
Eligibility criteria

Age ≥18 years at the time of informed consent signing, either sex; [+15]

Histologically or cytologically confirmed combined small cell lung cancer, neuro... [+14]