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

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). The

Trial Details

NCT ID

NCT05841472

Phase

PHASE2

Sponsor

CrystalGenomics, Inc.

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

Camrelizumab (SHR-1210), Pemetrexed, and Carboplatin

Locations (sample)

Anam, South Korea|36.8486,129.2272
Anyang, South Korea|36.4361,128.1305
Hwasun, South Korea|35.06125,126.98746
Seoul, South Korea|37.566,126.9784
Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

Subject aged between 19-80 at the time of signing the informed consent form, male or female.
Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), Stage IIIB-IV (as per the International Association for …
The site must provide documented information on EGFR mutation and ALK translocation and both must be negative. Subject cannot be randomized before …
A tumor tissue specimen collected upon or after diagnosis of advanced or metastatic disease, either fresh or archival (within 6 months prior to the…

For full eligibility, visit ClinicalTrials.gov.

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