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Lung cancer combo trial halted early – what we know

NCT ID NCT04585815

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested the immunotherapy drug sasanlimab combined with various targeted therapies in 34 people with advanced non-small cell lung cancer. The goal was to check safety and find the right doses. However, the study was terminated early, meaning we have limited data on how well these combinations work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sasanlimab (an immunotherapy drug) combined with other targeted drugs (encorafenib, binimetinib, axitinib, SEA-TGT)
What this could lead to
If successful, this could point toward new combination treatments for advanced non-small cell lung cancer, especially for patients with specific genetic mutations.
What could go wrong
The trial was terminated early, so results are limited. It was a small, early-phase study (phase 1b/2) focused on safety and dosing, not yet proving effectiveness. Combination therapies also carry higher risk of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

34 people

The number who actually took part.

Started

Nov 2020

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Advent Health Orlando - Investigational Drug Services

    Orlando, Florida, 32804, United States

  • AdventHealth Celebration Infusion Center

    Celebration, Florida, 34747, United States

  • AdventHealth Medical Group Oncology Research at Celebration

    Celebration, Florida, 34747, United States

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • AdventHealth Orlando Infusion Center

    Orlando, Florida, 32804, United States

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650, Belgium

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • California Cancer Associates for Research and Excellence, Inc (cCARE)

    Fresno, California, 93720, United States

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • City of Hope

    Duarte, California, 91010, United States

  • City of Hope Investigational Drug Services (IDS)

    Duarte, California, 91010, United States

  • Concord Hospital

    Concord, New South Wales, 2139, Australia

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065, Australia

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Henry Ford Medical Center - Columbus

    Novi, Michigan, 48377, United States

  • Henry Ford Medical Center - Fairlane

    Dearborn, Michigan, 48126, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Koman Family Outpatient Pavilion

    La Jolla, California, 92037, United States

  • Koo Foundation Sun Yat -Sen Cancer Center

    Taipei, 112, Taiwan

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112, Taiwan

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Mount Sinai Hospital Pharmacy

    New York, New York, 10029, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • North Shore Radiology and Nuclear Medicine

    St Leonards, New South Wales, 2065, Australia

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203, United States

  • Sulpizio Cardiovascular Center at UC San Diego Health

    La Jolla, California, 92037, United States

  • Tennessee Oncology PLLC

    Dickson, Tennessee, 37055, United States

  • Tennessee Oncology PLLC

    Franklin, Tennessee, 37067, United States

  • Tennessee Oncology PLLC

    Gallatin, Tennessee, 37066, United States

  • Tennessee Oncology PLLC

    Hendersonville, Tennessee, 37075, United States

  • Tennessee Oncology PLLC

    Hermitage, Tennessee, 37076, United States

  • Tennessee Oncology PLLC

    Lebanon, Tennessee, 37090, United States

  • Tennessee Oncology PLLC

    Murfreesboro, Tennessee, 37129, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37205, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37207, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37211, United States

  • Tennessee Oncology PLLC

    Shelbyville, Tennessee, 37160, United States

  • Tennessee Oncology PLLC

    Smyrna, Tennessee, 37167, United States

  • The Oncology Institute of Hope and Innovation

    Glendale, California, 91204, United States

  • The Oncology Institute of Hope and Innovation

    Long Beach, California, 90805, United States

  • The Oncology Institute of Hope and Innovation

    Los Angeles, California, 90015, United States

  • The Oncology Institute of Hope and Innovation

    Santa Ana, California, 92705, United States

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602, United States

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103, United States

  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

    La Jolla, California, 92037, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UC San Diego Moores Cancer Center - Investigational Drug Services

    La Jolla, California, 92037, United States

  • UCSD Medical Center - Encinitas

    Encinitas, California, 92024, United States

  • UCSD Medical Center - Vista

    Vista, California, 92081, United States

  • UCSD Perlman Medical Offices

    La Jolla, California, 92037, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UZ Leuven

    Leuven, 3000, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.