Phase III study of Pembrolizumab versus Pembrolizumab plus Carboplatin plus Pemetrexed for non-Sq NSCLC with PD-L1 50% or more

Phase 3

Recruiting

Conditions: non-squamous non-small cell lung cancer
non-squamous non-small cell lung cancer, pembrolizumab, PD-L1, carboplatin, pemetrexed

Registration Number: JPRN-jRCTs031200078

Lead Sponsor: Kogure Yoshihito

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 290

Inclusion Criteria

1) Non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology.
2) Not received prior systemic treatment with stage III not eligible for radical radiotherapy, stage IV, or recurrent NSCLC.
3) PD-L1 TPS of 50% or more with 22C3 antibody.
4) With at least one measurable lesion based on RECIST 1.1.
5) Age of 20 years or older on the day of informed consent.
6) ECOG Performance Status 0-1.
7) Without activating mutation in EGFR or ALK chromosomal translocation.
8) Absence of severe impairments of major organs.
9) Life expectancy of 12 weeks or more from the treatment start date.
10) Prior to the study registration, able to provide written informed consent after a thorough explanation of the study content.

Exclusion Criteria

1) Has symptomatic brainmetastasis with anti-edematic drugs such as steroids (exceeding 5mg prednisolone/day or equivalent)
2) Has a known sensitivity to any component of protocol therapy drug
3) Has symptomatic ascites or pleural effusion
4) Has active autoimmune disease
5) Is on chronic systemic steroids
6) Completed palliative radiotherapy within 7 days of the first dose of the treatment or Received radiation therapy to the lung that exceeds 30 Gy within 6 months of the first dose of the study treatment
7) Has a history of malignancy
8) Has an active infection or severe complications
9) Is expecting to conceive or father children within the projected duration of the study
10) Has known active Hepatitis B or C
11) not eligible in the opinion of the principal investigator