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New drug combo takes on tough lung cancer

NCT ID NCT07226999

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 18, 2026 · Updated 6 times

Summary

This study tests a new medicine called PF-08634404 given with chemotherapy for adults with extensive-stage small cell lung cancer, a fast-growing cancer that has spread. The trial has two parts: first checking safety, then comparing the new combo to an approved treatment (atezolizumab plus chemo). About 550 participants will receive IV infusions in cycles.

What this could mean

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

Active substance
PF-08634404 (a new experimental drug) given with chemotherapy
What this could lead to
If it works, this could offer a new treatment option for people with extensive-stage small cell lung cancer, potentially improving survival.
What could go wrong
This is an early-to-mid stage trial, so the drug may not work better than existing treatments. Side effects from the new drug combination are unknown.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Mar 2034

An estimate. End dates often move.

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: * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC. * Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC * Have at least one measurable lesion as the targeted lesion based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression * Leptomeningeal disease * Clinically significant risk of hemorrhage or fistula * history of another malignancy within 3 years * active autoimmune diseases requiring systemic treatment within the past 2 years

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

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

Small cell lung cancer ( SCLC )

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    83 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    RECRUITING

    Orbassano, Turin, 10043, Italy

  • BRCR Coral Springs

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • BRCR Global - Tamarac

    RECRUITING

    Tamarac, Florida, 33321, United States

  • CETIR

    RECRUITING

    Barcelona, 08029, Spain

  • Centro di Riferimento Oncologico (CRO) IRCCS

    RECRUITING

    Aviano, Pordenone, 33081, Italy

  • Doctor's Center Hematology & Oncology Group

    RECRUITING

    Manati, 00674, Puerto Rico

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • HT Médica Jaen LAs Nieves

    RECRUITING

    Jaén, Andalusia, 23007, Spain

  • Highlands Oncology Group

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • Highlands Oncology Group

    RECRUITING

    Rogers, Arkansas, 72758, United States

  • Highlands Oncology Group

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Hospital Jerez de la Frontera

    RECRUITING

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Oncologico Dr. Isaac Gonzalez-Martinez

    RECRUITING

    San Juan, 00935, Puerto Rico

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario de Jaen

    RECRUITING

    Jaén, 23007, Spain

  • Hôpital Ambroise Paré

    RECRUITING

    Boulogne-Billancourt, Île-de-France Region, 92100, France

  • IRCCS Istituto Nazionale dei Tumori Regina Elena

    RECRUITING

    Roma, ROME, 00144, Italy

  • Japanese Foundation for Cancer Research

    RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Krankenhaus Nordwest GmbH

    RECRUITING

    Frankfurt am Main, 60488, Germany

  • Marien Hospital Düsseldorf

    RECRUITING

    Düsseldorf, 40479, Germany

  • Mid Florida Hematology and Oncology Center

    RECRUITING

    Orange City, Florida, 32763, United States

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704302, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    RECRUITING

    Blacksburg, Virginia, 24060, United States

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    RECRUITING

    Low Moor, Virginia, 24457, United States

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    RECRUITING

    Salem, Virginia, 24153, United States

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    RECRUITING

    Wytheville, Virginia, 24382, United States

  • Pan American Center for Oncology Trials LLC

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center

    RECRUITING

    Mayagüez, 00680, Puerto Rico

  • Parc de Salut Mar - Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • Sunshine Coast University Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Arlington, Texas, 76012, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Arlington, Texas, 76014, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Bedford, Texas, 76022, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Dallas, Texas, 75203, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Dallas, Texas, 75230, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Dallas, Texas, 75231, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Dallas, Texas, 75237, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76104, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Grapevine, Texas, 76051, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Plano, Texas, 75075, United States

  • Texas Oncology - DFW

    NOT_YET_RECRUITING

    Plano, Texas, 75093, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Houston, Texas, 77024, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Houston, Texas, 77054, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Pearland, Texas, 77584, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Webster, Texas, 77598, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Allen, Texas, 75013, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Denison, Texas, 75020, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Denton, Texas, 76201, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Flower Mound, Texas, 75028, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Lewisville, Texas, 75056, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Longview, Texas, 75601, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    McKinney, Texas, 75071, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Palestine, Texas, 75801, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Paris, Texas, 75460, United States

  • Texas Oncology - Northeast Texas

    NOT_YET_RECRUITING

    Tyler, Texas, 75702, United States

  • Texas Oncology - San Antonio

    RECRUITING

    Fredericksburg, Texas, 78624, United States

  • Texas Oncology - San Antonio

    RECRUITING

    New Braunfels, Texas, 78130, United States

  • Texas Oncology - San Antonio

    RECRUITING

    San Antonio, Texas, 78217, United States

  • Texas Oncology - San Antonio

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Texas Oncology - San Antonio

    RECRUITING

    San Antonio, Texas, 78258, United States

  • US Oncology Investigational Product Center (IPC)

    RECRUITING

    Irving, Texas, 75063, United States

  • US Oncology Investigational Products Center (IPC)

    RECRUITING

    Irving, Texas, 75063, United States

  • US Oncology Investigational Products Center (IPC)

    NOT_YET_RECRUITING

    Irving, Texas, 75063, United States

  • University Hospitals Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Virginia Oncology Associates

    RECRUITING

    Chesapeake, Virginia, 23320, United States

  • Virginia Oncology Associates

    RECRUITING

    Hampton, Virginia, 23666, United States

  • Virginia Oncology Associates

    RECRUITING

    Newport News, Virginia, 23606, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Virginia Oncology Associates

    RECRUITING

    Virginia Beach, Virginia, 23456, United States

  • Virginia Oncology Associates

    RECRUITING

    Williamsburg, Virginia, 23188, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

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