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A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients

ConditionNon-squamous Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Shengdi Pharmaceutical Co., Ltd

About this trial

Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.

At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.

Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.

At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .

Disqualifiers

Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.

Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.

Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.

Subjects with inadequately controlled pain related to their tumor(s).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin

    Drug

    Adebrelimab,1200mg; SHR-8068, 1.0 mg/kg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

  • Camrelizumab + Pemetrexed + Carboplatin

    Drug

    Camrelizumab,200mg;Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

  • Adebrelimab + Pemetrexed + Carboplatin

    Drug

    Adebrelimab,1200mg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

Treatment groups

401 Participants
are divided into 3 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BActive comparator 1 intervention
Group C: Treatment group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Investigator-assessed Objective Response Rate (Phase One)

Time frame
about 3 years
2

Overall Survival (Phase Two)

Time frame
about 3.5 years

Secondary outcomes

1

The incidence and severity of Adverse Events (AEs) (Phases One and Two)

Time frame
about 4.5 years
2

Duration of Response (DoR) based on Investigator Assessment (Phases One and Two)

Time frame
about 6.5 years
3

Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two)

Time frame
about 6.5 years
4

Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two)

Time frame
about 6.5 years

Other outcomes

Sponsors and contacts

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

Shanghai Shengdi Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: