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New hope for rare lung cancer: experimental drug combo enters human trials

NCT ID NCT07476287

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study tests a new medicine called PF-08634404 given with chemotherapy for adults with transformed small cell lung cancer (T-SCLC), a rare and aggressive cancer that develops from another lung cancer type. About 40 participants will receive the drug combo through IV infusions, then continue the study drug alone. The main goal is to see if tumors shrink and to check for side effects.

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 (also called SSGJ-707) given with chemotherapy
What this could lead to
If it works, this could offer a new treatment option for people with transformed small cell lung cancer, a rare and aggressive cancer that currently has few options.
What could go wrong
This is an early Phase 2 trial with only 40 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects like those from chemotherapy.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Started

Jul 2026

Expected to finish

Mar 2031

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: * Male or female participants aged ≥18 years at the time of informed consent. * Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s). * Participants have not received systemic therapy for T-SCLC. * Have at least one measurable lesion as the target lesion based on RECIST v1.1. * Have sufficient tumor tissue from the diagnosis of transformed SCLC available. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Have a minimum life expectancy of \>12 weeks. * Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \<1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features. * Leptomeningeal disease * Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula * History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer) * Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable) * History of allogeneic organ or hematopoietic stem cell transplantation * Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol) * Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including: * Prior or current non-infectious pneumonitis requiring systemic therapy * DLCO \<50% predicted * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement * Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose * Baseline QTcF \>480 msec * Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study * Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage * History of significant bleeding disorders or recent major bleeding events * Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding * Active, uncontrolled, or symptomatic infection, including: * Active TB * Active hepatitis B or C * Uncontrolled HIV infection * History of immunodeficiency * Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies * Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation * Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods * Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes * Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer) * Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements

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Conditions

The condition(s) this trial relates to.

lung neoplasm small cell lung carcinoma

As listed by the trial registrant

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

Carcinoma, small cell lung Lung neoplasms Small cell cancer of the lung Small cell lung cancer Small cell lung cancer ( SCLC ) Transformed small cell lung cancer

How to take part

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

  1. The places running it

    30 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

  • A.O.U. San Luigi Gonzaga

    NOT_YET_RECRUITING

    Orbassano, Turin, 10043, Italy

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, 69373, France

  • City of Hope Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni

    NOT_YET_RECRUITING

    Bergamo, 24125, Italy

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350014, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hope and Healing Clinical Research

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Hope and Healing Clinical Research

    RECRUITING

    New Lenox, Illinois, 60451, United States

  • Hospital São Lucas da PUCRS

    RECRUITING

    Porto Alegre, 90610-000, Brazil

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • IRCCS Istituto Nazionale dei Tumori Regina Elena

    NOT_YET_RECRUITING

    Roma, ROME, 00144, Italy

  • Institut Català d'Oncologia - L'Hospitalet

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, VAL DE Marne, 94805, France

  • Japanese Foundation for Cancer Research

    RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • National Cancer Center - Tsukiji Campus

    RECRUITING

    Chūō, Tokyo, 104-0045, Japan

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704302, Taiwan

  • National Taiwan University Cancer Center (NTUCC)

    RECRUITING

    Taipei, 106, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Osaka International Cancer Institute(OICI)

    RECRUITING

    Osaka, 541-8567, Japan

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Queen Mary Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9103102, Israel

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, HA Merkaz, 5265601, Israel

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330200, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430048, China

More trials for these conditions

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