Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer

JRCT ID: jRCT2051240178

Registered date:05/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: PD-L1 positive metastatic non-small cell lung cancer
• Date of first enrollment: 20/11/2024
• Target sample size: 72
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,Croatia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Italy,Japan,Korea,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan,Estonia,Japan,Portugal,Japan
• Study type: Interventional
• Intervention(s): To receive either acasunlimab (100 mg) and pembrolizumab (400 mg) once every 6 weeks (Q6W) (Arm A) or Docetaxel 75 mg/m2 once every 3 weeks (Q3W) (Arm B).

Outcome(s)

• Primary Outcome: Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Participant has histologically or cytologically confirmed metastatic NSCLC
(stage IV).
- Participant has progressed on or after receiving:
- One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR
- No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order)in the metastatic disease setting.
- Participant must have positive tumor PD-L1 expression (tumor cells >=1%)determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.
- Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
- Participant has a life expectancy of >=3 months.
- Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.

Exclude criteria

- Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), BRAF mutations, and MET exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test.
- Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
- Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
- Prior treatment with docetaxel for NSCLC.
- Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
- Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.

Related Information

• Primary Sponsor: jRCT Inquiry Receipt Center