Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
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| ClinicalTrials.gov Identifier: NCT05117242 |
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Recruitment Status :
Recruiting
First Posted : November 11, 2021
Last Update Posted : April 3, 2024
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Sponsor:
Genmab
Collaborators:
BioNTech SE
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Genmab
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Brief Summary:
The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer Metastatic | Biological: Acasunlimab Biological: Pembrolizumab | Phase 2 |
This trial is a randomized, open-label trial evaluating the safety and efficacy of acasunlimab (GEN1046) as monotherapy and in combination therapy with pembrolizumab.
The trial consists of two parts; a safety phase and an extension phase. The extension phase will be initiated once the safety phase is completed.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor |
| Actual Study Start Date : | October 27, 2021 |
| Estimated Primary Completion Date : | November 2024 |
| Estimated Study Completion Date : | March 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information
available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A
Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles
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Biological: Acasunlimab
Acasunlimab will be administered intravenously (IV)
Other Names:
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Experimental: Arm B
Treatment with acasunlimab + pembrolizumab once every 21 days
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Biological: Acasunlimab
Acasunlimab will be administered intravenously (IV)
Other Names:
Biological: Pembrolizumab Pembrolizumab will be administered IV
Other Name: KEYTRUDA® |
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Experimental: Arm C
Treatment with acasunlimab+ pembrolizumab once every 42 days
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Biological: Acasunlimab
Acasunlimab will be administered intravenously (IV)
Other Names:
Biological: Pembrolizumab Pembrolizumab will be administered IV
Other Name: KEYTRUDA® |
Primary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: From first treatment to approximately 27 weeks after last subject's first dose ]ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per RECIST v1.1
Secondary Outcome Measures :
- Duration of response (DOR) [ Time Frame: From onset date of response until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months) ]DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v. 1.1 or death from any cause, whichever occurs first.
- Time to response (TTR) [ Time Frame: From first treatment to date of onset of initial response (CR or PR) as per RECIST v.1.1 (an expected average of 6 months) ]TTR will be measured as the time from first treatment to onset of initial response (CR or PR) as per RECIST v.1.1
- Progression-free survival (PFS) [ Time Frame: From first treatment to first documented progression or death due to any cause (an expected average of 6 months) ]PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v.1.1 or until death from any cause, whichever occurs first
- Overall survival (OS) [ Time Frame: From first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial) ]Defined as time to death from of any cause
- Incidence and severity of adverse events (AEs) and laboratory abnormalities [ Time Frame: Throughout the trial until end of safety follow-up period (60 days or 90 days after last dose) ]Incidence of treatment-emergent AEs as assessed by CTCAE v5.0. Laboratory parameters graded by CTCAE v5.0
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Have signed an informed consent form (ICF)
- Be at least 18 years of age.
- Have 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
- Have a tumor PD-L1 expression result available prior to first treatment demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a central or local laboratory during screening.
- Have measurable disease per RECIST v1.1.
- Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Have life expectancy of at least 3 months.
- Have adequate organ and bone marrow function as defined in the protocol.
Key Exclusion Criteria:
- Documentation of known EGFR, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET arrangement, ALK gene rearrangements, high-level MET amplification, or METex 14 skipping. Note: Subjects harboring such mutations, gene rearrangements or amplifications may be enrolled in the trial, if subjects have received prior approved targeted therapy for such mutations, the subject may still be eligible for this trial.
- Treatment with an anti-cancer agent within 28 days prior to acasunlimab administration.
- Any investigational agent for the treatment of stage 4 NSCLC.
- Radiotherapy within 14 days prior to first dose of acasunlimab. Note: palliative radiotherapy will be allowed for local pain control under certain conditions.
- Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone >10 mg daily or a cumulative dose >150 mg prednisone within 14 days before the first acasunlimab administration.
- Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Subject has contraindications to the use of pembrolizumab per local prescribing information.
- Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis (interstitial lung disease).
- Ongoing or active infection requiring intravenous treatment with anti-infective therapy or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
- Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia.
- Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management.
- Ongoing or recent (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
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Subject has a known history of any of the following:
- Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment.
- Myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
- Liver disease (eg, alcoholic hepatitis or non-alcoholic steatohepatitis, drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis).
- Organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of acasunlimab.
- Grade 3 or higher allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117242
Contacts
| Contact: Genmab A/S Trial Information | +45 70202728 | clinicaltrials@genmab.com |
Locations
Show 52 study locations
Sponsors and Collaborators
Genmab
BioNTech SE
Merck Sharp & Dohme LLC
| Responsible Party: | Genmab |
| ClinicalTrials.gov Identifier: | NCT05117242 |
| Other Study ID Numbers: |
GCT1046-04 2021-001928-17 ( EudraCT Number ) 1004314 ( Other Identifier: IRAS ID; UK Research Summaries Database ) |
| First Posted: | November 11, 2021 Key Record Dates |
| Last Update Posted: | April 3, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Genmab:
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DuoBody® Bispecific antibody PD-L1 4-1BB |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |