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

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

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

Treatments tested in this trial

  • Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin
  • Camrelizumab + Pemetrexed + Carboplatin
  • Adebrelimab + Pemetrexed + Carboplatin

Treatment groups

401 Participants
are divided into 3 treatment groups