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Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
EU CTIS ID: 2024-513770-22-00
What this study is testing
Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab therapy in subjects with relapsed/refractory metastatic NSCLC
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject must sign an informed consent form (ICF)
- Subject must be at least 18 years of age on the day of signing the ICF
- Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 -mAb for metastatic disease.
- Subject must have a tumor PD-L1 expression result available prior to C1D1 demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a sponsor designated central laboratory using the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%), or per site local assessment with the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%) or the VENTANA PD-L1 (SP263) assay (TC ≥1%) adhering to the manufacturer’s instructions. Note: Local PD-L1 result needs to be performed on fresh tumor tissue (obtained within 3 months prior to enrollment and after failure/stop of last prior treatment) or, if not feasible, archival tissue (obtained within 12 months prior to enrollment).
- Subject must have measurable disease per RECIST v1.1 as assessed by the investigator.
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
You likely can't join if
- Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements, highlevel MET amplification, or METex 14 skipping
- Subject has been exposed to any of the following prior therapies: •Prior treatment with docetaxel for NSCLC •Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, or autologous cell immunotherapy, •Treatment with an anti-cancer agent within 28 daysrior to GEN1046 administration.
See the full eligibility criteria
- Subject must sign an informed consent form (ICF)
- Subject must be at least 18 years of age on the day of signing the ICF
- Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 -mAb for metastatic disease.
- Subject must have a tumor PD-L1 expression result available prior to C1D1 demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a sponsor designated central laboratory using the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%), or per site local assessment with the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%) or the VENTANA PD-L1 (SP263) assay (TC ≥1%) adhering to the manufacturer’s instructions. Note: Local PD-L1 result needs to be performed on fresh tumor tissue (obtained within 3 months prior to enrollment and after failure/stop of last prior treatment) or, if not feasible, archival tissue (obtained within 12 months prior to enrollment).
- Subject must have measurable disease per RECIST v1.1 as assessed by the investigator.
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Subject must have life expectancy of at least 3 months
- Subject must have adequate organ and bone marrow function as described in the protocol.
- Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements, highlevel MET amplification, or METex 14 skipping
- Subject has been exposed to any of the following prior therapies: •Prior treatment with docetaxel for NSCLC •Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, or autologous cell immunotherapy, •Treatment with an anti-cancer agent within 28 daysrior to GEN1046 administration.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.