New drug combo targets rare lung cancer in early trial
NCT ID NCT07200947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug combination (iparomlimab and tuvonralimab) plus chemotherapy as a first treatment for people with a rare, advanced lung cancer that lacks the SMARCA4 gene. The goal is to see if this approach can shrink tumors or delay cancer growth. About 28 adults with this specific cancer type will take part. The study is not yet open for enrollment.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Participants must meet all of the following criteria to be eligible for the study: 1. Voluntary participation and provision of signed written informed consent. 2. Age ≥ 18 years. 3. Life expectancy ≥ 3 months. 4. Histologically or cytologically confirmed diagnosis of Stage IIIB-IV lung cancer that is not amenable to curative surgery or radiotherapy. 5. Tumor demonstrates loss of BRG1 protein (encoded by the SMARCA4 gene) as confirmed by immunohistochemistry (IHC). 6. No prior systemic anti-cancer therapy for advanced disease. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Willingness to provide archived or fresh tumor tissue samples from primary or metastatic lesions. If unavailable, enrollment may be permitted following investigator assessment. 9. At least one measurable lesion as defined by RECIST v1.1. 10. Adequate organ function within the screening period, as evidenced by: 10.1 Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L 10.2 Platelet count ≥ 100 × 10\^9/L 10.3 Hemoglobin ≥ 90 g/L (without transfusion within 14 days) 10.4 Serum creatinine ≤ 1 × ULN OR Creatinine clearance \> 50 mL/min (calculated by Cockcroft-Gault formula) 10.5 AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) 10.6 Total bilirubin ≤ 1.5 × ULN (except for participants with Gilbert's syndrome) 10.7 TSH, FT3, and FT4 within normal limits (±10%) Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Pathological diagnosis containing a small cell component. 2. Symptomatic brain metastases. 3. Leptomeningeal metastases. 4. Recurrence within 6 months after completing prior adjuvant therapy (if applicable). 5. Active, known, or suspected autoimmune disease (with specific exceptions, e.g., vitiligo, type I diabetes, hypothyroidism managed with hormone replacement only). 6. Active tuberculosis (TB) infection or history of active TB within the past year. 7. Comorbidities requiring immunosuppressive medications, including systemic corticosteroids at immunosuppressive doses. 8. Pregnancy or lactation in female participants. 9. Symptomatic interstitial lung disease that could interfere with the detection or management of suspected drug-related pulmonary toxicity. 10. Known HIV infection, active Hepatitis B (HBsAg positive with HBV-DNA \> 10\^3 copies/mL), or active Hepatitis C (HCV antibody positive with detectable HCV-RNA). 11. Significant history of neurological or psychiatric disorders. 12. Treatment with any investigational drug within 4 weeks prior to the first dose of study treatment. 13. Use of Chinese herbal medicines with anti-tumor activity within 2 weeks prior to study treatment initiation. 14. History of another active malignancy within the past 2 years (with specific exceptions for certain early-stage cancers). 15. Significant cardiovascular or cerebrovascular disease history. 16. Uncontrolled thrombotic events within 6 months prior to screening. 17. Administration of a live vaccine within 28 days prior to the first study dose. 18. Major surgery or significant trauma within 4 weeks prior to the first study dose. 19. Conditions that may impair oral drug absorption. 20. Uncontrolled active infection requiring systemic therapy. 21. Known hypersensitivity to any of the study drug components. 22. Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China
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Other studies related to the condition(s) this trial covers.
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