Health TrialsbyHealthPanel

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

ConditionsNon-Small Cell Lung CancerRET Driver MutationBRAF V600 MutationErb-B2 Receptor Tyrosine Kinase Exon 20 MutationMET AmplificationMET Exon 14 Skipping Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital

About this trial

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Toripalimab plus chemotherapy in rare mutations stage IIB-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 Years and older

ECOG physical score 0-1 points; expected survival time ≥ 3 months;

Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed) or exon 14 skipping. Suspected N2 disease should be confirmed by either mediastinoscopy or EBUS. N1 disease could be determined through PET/CT but biopsy of primary lung cancer is needed;

Lung function capacity capable of tolerating the proposed lung surgery

Disqualifiers

Stage I and stage IV NSCLC;

Patients who have previously used any other anti-tumor drugs or radiotherapy;

Large panel NGS indicated sensitive EGFR alteration, ALK fusion, ROS1 fusion or any other driver mutations combined with MDM2/MDM4 amplification;

Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);

Trial design

Design model

Single group

Treatments tested in this trial

  • Toripalimab

    Biological/Vaccine

    240mg Q3W

  • Nab paclitaxel

    Drug

    135 mg/m2, d1, 8 Q3W

  • Pemetrexed

    Drug

    500mg/m2, d1 Q3W

  • Carboplatin

    Drug

    AUC 5, d1 Q3W

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Toripalimab plus chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR)

Evaluation of the pathological complete response: The pathological complete response is defined as the absence of residual tumor in both lung and lymph nodes after neoadjuvant treatment.

Time frame
pCR will be assessed within 2 weeks after surgery

Secondary outcomes

1

Major Pathological Response (MPR)

Percentage of Participants with Major Pathologic Response. MPR was defined as percentage of tumor cells within tumor bed less than 10% for both primary lung lesions and metastatic lymph nodes.

Time frame
MPR will be assessed within 2 weeks after surgery
2

Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the length of time from initiation of neoadjuvant treatment to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause.

Time frame
From date of initiation of neoadjuvant treatment to disease progression, reoccurrence, or death due to any cause, up to 36 months.
3

Overall Survival (OS)

Overall survival (OS) is defined as the time between the date of initiation of neoadjuvant treatment and the date of death.

Time frame
From date of initiation of neoadjuvant treatment to the date of all-cause death, assessed up to 60 months.
4

Adverse Events (AEs)

Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment or surgery.

Time frame
From date of initiation of neoadjuvant treatment till treatment discontinuation, assessed up to 14 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Collaborator

Source ClinicalTrials.gov
Apply now