Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Sponsor
CrystalGenomics, Inc.
Study ID
NCT05841472
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non Squamous Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab (SHR-1210), Pemetrexed, and Carboplatin — DRUG
    * 200 mg of Camrelizumab (SHR-1210) is administered intravenously over a period of around 20-60 min on Day 1 of each 3-week cycle. * Pemetrexed 500 mg/m2 is administered intravenously on Day 1 of each 3-week cycle, over a period of more than 10 minutes * Carboplatin of AUC 5 is administered intravenously on Day 1 of each 3-week cycle (hydrated as appropriate), over a period of more than 30 minutes by 4-6 cycles.

Study Details

The objective of this bridging study is to acquire new drug approval in Korea for camrelizumab (SHR-1210), a drug that has already been approved in China for treatment in patients with histologically or cytologically confirmed advanced or metastatic (Stage IIIB-IV), EGFR/ALK wild-type, non-squamous, non-small cell lung cancer. In this study, subjects with advanced or metastatic, EGFR/ALK wild-type, non-squamous, non-small lung cancer will receive anti-PD-1 antibody therapy of camrelizumab in combination with pemetrexed + carboplatin as first-line treatment for at least 8 cycles (24 weeks). Then, the best overall RECIST responses (BOR) from subjects who have had at least 1 post-baseline tumor assessment will be evaluated to confirm that camrelizumab, a drug that has already been approved China, has similar efficacy in the Korean population as in the Chinese population.

Key Dates

Start date
Aug 23, 2023
Status verified
Aug 2023
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab, Pemetrexed and Carboplatin

Primary Outcome Measure

Best overall RECIST response, BoR [ Time Frame: up to 8 cycles (24 weeks) of the last subject ]

Central Contacts

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