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

Sponsor
Shanghai Shengdi Pharmaceutical Co., Ltd
Study ID
NCT06335355
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Mar 31, 2024
Status verified
Mar 2024
Primary completion
Oct 31, 2028
Completion
Oct 31, 2030

Study Design

Enrollment
401 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
  • Active Comparator: Treatment group B
  • Active Comparator: Treatment group C

Primary Outcome Measure

Investigator-assessed Objective Response Rate (Phase One) [ Time Frame: about 3 years ]

Central Contacts

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