A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)
This trial is being run to evaluate whether the trial drug acasunlimab in combination with pembrolizumab works better than standard of care chemotherapy treatment with docetaxel in subjects who have metastatic NSCLC.
The purpose of this phase 3 trial is to evaluate the efficacy and safety of acasunlimab + pembrolizumab versus docetaxel in subjects with PD-L1 positive tumors who have progressed after PD-1/PD-L1 inhibitor
and platinum-containing chemotherapy in the metastatic setting of NSCLC.
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Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV).
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Participant has progressed on or after receiving:
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One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR
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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.
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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.
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Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
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Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
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Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS protooncogene 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.
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Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
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Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
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Prior treatment with docetaxel for NSCLC.
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Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine,autologous cell immunotherapy, or any unapproved immunotherapy.
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Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
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