Trial record 1 of 1 for:
B8011011
Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT04585815 |
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Recruitment Status :
Recruiting
First Posted : October 14, 2020
Last Update Posted : August 18, 2021
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
Phase 1b/Phase 2 open-label, multi-center, parallel group umbrella study.
Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: Sasanlimab Prefillled syringe Drug: Encorafenib Drug: Binimetinib Drug: Sasanlimab Drug: Axitinib Drug: SEA-TGT | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 375 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC) |
| Actual Study Start Date : | November 10, 2020 |
| Estimated Primary Completion Date : | November 27, 2024 |
| Estimated Study Completion Date : | January 17, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sub-Study A
Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.
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Drug: Sasanlimab Prefillled syringe
prefilled syringe Drug: Encorafenib capsules Drug: Binimetinib tablets |
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Experimental: Sub-Study B
Sasanlimab will be administered subcutaneously. Axitinib will be administered orally. SEA-TGT will be administered intravenously. Treatments will be administered until progressive disease, unacceptable AE, patient withdraws, or study is terminated.
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Drug: Sasanlimab
solution supplied in vials Drug: Axitinib tablets Drug: SEA-TGT solution in vials |
Primary Outcome Measures :
- Percentage of participants with Dose-limiting toxicities (DLT) [ Time Frame: First dose (Cycle 1 Day 1) to end of first treatment cycle (about 21-28 days) ]Phase 1 Primary Outcome: DLTs are a predefined set of observed adverse events that are at least possibly related to at least 1 of the investigational agents.
- Durable Objective Response Rate - Percentage of Participants With Objective Response [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days ]Sub-Study A only, Phase 2 only: Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) lasting for at lease 10 months, according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Objective Response Rate-Percentage of Participants with Objective Response [ Time Frame: First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 21 days ]Sub-Study B only, Phase 2 only: Percentage of participants with CR or PR, according to RECIST v1.1.
Secondary Outcome Measures :
- Number of participants with Treatment-Emergent Adverse Events [ Time Frame: First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 1b and Phase 2
- Percentage of participants with Treatment-Emergent Adverse Events [ Time Frame: First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 1b and Phase 2
- Number of Participants with Treatment-Emergent Laboratory Abnormalities [ Time Frame: First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 1b and Phase 2
- Percentage of Participants with Treatment-Emergent Laboratory Abnormalities [ Time Frame: First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 1b and Phase 2
- Durable Objective Response Rate - Percentage of Participants With Objective Response [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Sub-Study A only, Phase 1b only: Percentage of participants with confirmed CR or PR lasting for at lease 10 months, according to RECIST v1.1
- Objective Response Rate-Percentage of Participants with Objective Response [ Time Frame: First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Sub-study A Phase 1 and Phase 2, Sub-Study B, Phase 1 only: Percentage of participants with CR or PR, according to RECIST v1.1.
- Duration of Response (DR) [ Time Frame: First objective response to progressive disease or death (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 2 only
- Time to Tumor Response (TTR) [ Time Frame: First dose (Cycle 1 Day 1) up to first objective response. Each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 2 only: The time from first dose to first documentation of objective tumor response of CR or PR.
- Progression-Free Survival (PFS) [ Time Frame: First dose (Cycle 1 Day 1) to progressive disease or death (up to about 24 months). Each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 2 only
- Overall Survival [ Time Frame: First dose (Cycle 1 Day 1) to death (up to about 40 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 2 only
- Incidence of Anti-Drug Antibody (ADA) for the study drugs [ Time Frame: First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B ]Phase 1b and Phase 2
- Neutalizing antibody (NAb) titers for sasanlimab [ Time Frame: First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days ]Sub-Study A only, Phase 1b and Phase 2
- Association between Objective Response and PD-L1 expression at baseline [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B. ]Phase 2 only
- PK Parameter Ctrough [ Time Frame: First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). About 1-3 draws per Cycle for the first year, and then every 6 cycles until EOT. Each cycle is about 28 days in Sub-Study A and 21 days in Sub-Study B. ]Phase 1b and Phase 2: Ctrough of the study drugs when administered in combination, as data permit.
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days ]Sub-Study A only, Phase 2 only; EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
- European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days ]Sub-Study A only, Phase 2 only; QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days ]Sub-Study A only, Phase 2 only; EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score [ Time Frame: First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days ]Sub-Study A only, Phase 2 only; QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
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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
Inclusion Criteria Umbrella Phase 1b & 2:
- Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.
- At least one measurable lesion per RECIST v1.1 at Screening.
- ECOG Performance Status 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Adequate hepatic, renal, and bone marrow function.
Additional Inclusion Criteria for Sub-Study A Phase 1b &2:
-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.
Additional Inclusion Criteria for Sub-Study A Phase 1b only:
-Any line of therapy for locally advanced/metastatic NSCLC.
Additional Inclusion Criteria for Sub-Study A Phase 2 only:
-Previously untreated for locally advanced/metastatic NSCLC
Additional Inclusion Criteria for Sub-Study B Phase 1b only::
-Any line of therapy for locally advanced/metastatic NSCLC.
Additional Inclusion Criteria for Sub-Study B Phase 2 only:
- Previously untreated for locally advanced/metastatic NSCLC (Arms B1 & B2), or
- One or 2 prior lines of therapy for advanced/metastatic NSCLC (Arm B3), including immune checkpoint inhibitor treatment + chemotherapy, and have progressed during or after that therapy.
- PD-L1 TPS ≥1%
Exclusion Criteria Umbrella Phase 1b &2:
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.
- Active infection requiring systemic therapy.
- Clinically significant cardiovascular disease.
- Other malignancy within 2 years of first dose, with exceptions.
- Symptomatic brain metastasis, with exceptions.
Additional Exclusion Criteria for Sub-Study A Phase 1b&2:
- EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
- Prior treatment with any BRAF inhibitor or MEK inhibitor.
Additional Exclusion Criteria for Sub-Study A Phase 2 only:
-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
Additional Exclusion Criteria for Sub-Study B Phase 1b&2:
-Documentation of any tumor-driving molecular alteration (eg, BRAF, EGFR, ALK)
Additional Exclusion Criteria for Sub-Study B Phase 2 only:
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.(Arms B1 & B2)
- Confirmed progressive disease on 1st or 2nd imaging tumor assessment after initiation of therapy for advanced/metastatic NSCLC.
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): NCT04585815
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 52 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT04585815 |
| Other Study ID Numbers: |
B8011011 2020-002829-28 ( EudraCT Number ) |
| First Posted: | October 14, 2020 Key Record Dates |
| Last Update Posted: | August 18, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer:
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Non-Small-Cell Lung Carcinoma NSCLC non small cell lung cancer non-small cell lung cancer BRAF mutation BRAF V600e BRAF B-RAF NSCLC lung cancer immunotherapy sasanlimab encorafenib binimetinib |
axitinib SEA-TGT TIGIT locally advanced metastatic ECOG 0 ECOG 1 Stage 3B Stage IV previously untreated second-line therapy first-line therapy |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Axitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |