What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that involve immune checkpoint inhibitors, such as pembrolizumab and nivolumab, are associated with a range of immune-related adverse events (irAEs). These side effects include fatigue, rash, diarrhea, and pruritus. More severe irAEs can involve pneumonitis, colitis, hepatitis, endocrinopathies (like hypothyroidism or adrenal insufficiency), and nephritis. Management of these side effects often requires corticosteroids or other immunosuppressive agents.

What prior FDA approvals exist?

Several PD-1 inhibitors have been approved by the FDA for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, a PD-1 monoclonal antibody, has been approved for use in combination with chemotherapy for advanced NSCLC, as well as monotherapy for tumors with high PD-L1 expression. Nivolumab, another PD-1 inhibitor, has shown efficacy in previously treated advanced NSCLC. Additionally, combinations such as nivolumab with ipilimumab (a CTLA-4 inhibitor) have been explored for their synergistic effects. Atezolizumab, a PD-L1 inhibitor, has also been approved in combination with chemotherapy for certain types of NSCLC. These treatments highlight the evolving landscape of immunotherapy in NSCLC, similar to the investigational use of Sasanlimab.

What other types of research exist?

Promising alternatives to Sasanlimab for NSCLC patients include: 1) Atezolizumab, which has shown complete response in patients progressing on other treatments; 2) Pembrolizumab, which has improved OS and PFS when combined with chemotherapy in both squamous and nonsquamous NSCLC; 3) Sintilimab, which has shown efficacy in combination with chemotherapy in nonsquamous NSCLC. These alternatives have demonstrated significant clinical benefits in recent trials.

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Monoclonal Antibodies

Immunotherapy + Targeted Therapy for Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report (Sub-Study A Phase 1b & 2)

Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC

Must not have

EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement (Sub-Study A Phase 1b&2)

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for advanced lung cancer that combines sasanlimab, which boosts the immune system, with other medicines that target cancer cells. It aims to see if this combination is safe and effective for patients whose cancer has spread outside the lungs.

Who is the study for?

This trial is for adults with advanced Non-small Cell Lung Cancer (NSCLC) who have specific genetic mutations like BRAFV600E, adequate organ function, and no prior treatments for metastatic NSCLC in certain sub-studies. It excludes those with autoimmune diseases, previous treatment with similar drugs or immunotherapy, significant heart disease, other recent cancers or certain lung conditions.

What is being tested?

The study tests Sasanlimab (an immune therapy drug) combined with targeted cancer therapies like Encorafenib and Binimetinib. The first phase checks safety and dosage; the second phase assesses how well these combinations work against tumors.

What are the potential side effects?

Potential side effects include typical reactions to immunotherapies such as fatigue, skin issues, inflammation of organs like the lungs or intestines, hormonal gland problems, liver toxicity and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor or blood test shows a BRAFV600E mutation.

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My lung cancer is at an advanced stage (Stage IIIB-IV).

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My liver, kidneys, and bone marrow are working well.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has an EGFR mutation, ALK fusion, or ROS1 rearrangement.

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I am currently on medication for an infection.

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I have a serious heart condition.

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I have lung inflammation not caused by an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)

Phase 1b of Sub-Study B: Percentage of Participants With DLT

Phase 2 Sub-Study B: Objective Response Rate

+1 more

Secondary study objectives

Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab

Phase 1b of Sub-Study A: Durable Objective Response Rate

Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

+29 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sub-Study BExperimental Treatment3 Interventions

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.

Group II: Sub-Study AExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Encorafenib

2022

Completed Phase 3

~970

Axitinib

2020

Completed Phase 2

~3050

Binimetinib

2018

Completed Phase 3

~1250

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies such as PD-1/PD-L1 inhibitors. These drugs, like Sasanlimab, work by blocking the interaction between the PD-1 protein on T-cells and the PD-L1 protein on cancer cells. This blockade prevents the cancer cells from evading the immune system, thereby allowing T-cells to recognize and attack the tumor. This mechanism is crucial for NSCLC patients as it enhances the body's natural immune response against cancer, potentially leading to better outcomes and prolonged survival.