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

JRCT ID: jRCTs031200078

Registered date:05/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-squamous non-small cell lung cancer
• Date of first enrollment: 13/08/2020
• Target sample size: 290
• Study type: Interventional

Intervention(s)

Group A: 200 mg of Pembro is intravenously infused over 30 minutes and more on day 1. Repeat the administration every 3 weeks as one cycle until the treatment cessation criteria are met. Upper limit of the Pembro administration is 35 cycles.
Group B: 200 mg of Pembro, AUC 5 of Carboplatin and 500mg/m2 of Pemetrexed are intravenously infused on day 1. Carboplatin will finished up to 4 cycles. Repeat the administration every 3 weeks as one cycle until the treatment cessation criteria are met for the other drugs. When CR, PR or SD will be achieved after 4 cycles, maintenance therapy with Pembrolizumab plus Pemetrexed will be continued. Pembrolizumab will finished up to 35 cycles.

Outcome(s)

• Primary Outcome: progression free survival

Secondary Outcome

objective response rate
overall survival
toxicity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Kogure Yoshihito
• Source(s) of Monetary Support: National Hospital Organization collaborative clinical research grant