New combo therapy aims to boost lung cancer survival
NCT ID NCT07632365
First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This study tests a new treatment plan for people with advanced non-small cell lung cancer that cannot be removed by surgery. Participants first receive chemotherapy plus immunotherapy, then radiation with more chemo, followed by additional immunotherapy. The goal is to see if this intensive approach can improve how long patients live without their cancer growing, while keeping side effects manageable. About 30 people will take part in this early-phase trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chemotherapy combined with a PD-1 inhibitor (immunotherapy)
- What this could lead to
- If successful, this approach could improve long-term survival for people with advanced lung cancer that cannot be surgically removed.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply to everyone. Combining treatments also raises the risk of serious 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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 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: 1. Age \>18 years, male or female, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 3. Unresectable stage III NSCLC (according to the 8th edition of the AJCC staging system). 4. No prior exposure to any other anti-tumor therapy. 5. Absence of severe medical comorbidities or major organ dysfunction, as assessed by hematology, hepatic, renal, cardiac, and pulmonary function tests, meeting the following criteria: Hematology: Hemoglobin (HB) ≥ 90 g/L (without blood transfusion within 14 days prior to enrollment); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L. Biochemistry: Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum creatinine (Cr) ≤ 1 × ULN, with an endogenous creatinine clearance rate \> 60 mL/min (calculated using the Cockcroft-Gault formula). Coagulation: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is receiving anticoagulant therapy, in which case PT or aPTT must be within the expected therapeutic range for the anticoagulant used). 6. Life expectancy ≥ 3 months. 7. Adequate understanding of the study, ability to complete treatment, suitability for follow-up, and voluntary provision of written informed consent. Exclusion Criteria: 1. Presence of small cell carcinoma components in the histological examination results. 2. Co-occurrence of EGFR mutation, ALK rearrangement, or ROS-1 rearrangement positivity. 3. History of other primary malignancies, with the following exceptions: Malignancies treated with curative intent with no known active disease and low potential for recurrence for ≥5 years prior to the first dose of investigational product (IP); adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease. 4. Active or documented history of autoimmune or inflammatory diseases (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[excluding diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, granulomatosis with polyangiitis \[Wegener's syndrome\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). 5. History of allogeneic organ transplantation. 6. History of active primary immunodeficiency. 7. Presence of uncontrolled concurrent illness, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus \[HIV\], etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), severe chronic gastrointestinal disease associated with diarrhea, or psychiatric disorders/social situations that would limit compliance with study requirements, substantially increase the risk of adverse events (AEs), or compromise the patient's ability to provide written informed consent. 8. Female patients who are pregnant or breastfeeding. 9. Concurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of induction immunotherapy. Exceptions include: intranasal, inhaled, or topical corticosteroids, or local corticosteroid injections (e.g., intra-articular injection); systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or its equivalent; corticosteroids as prophylactic premedication for hypersensitivity reactions (e.g., premedication for computed tomography \[CT\] scan); or systemic corticosteroid administration administered as part of chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC), or administered prophylactically or for the management of toxicity induced by chemotherapy and/or radiotherapy. 10. Known allergy or hypersensitivity to any study drug or any excipient of a study drug. 11. Patients judged by the investigator to be unable to comply with study procedures, restrictions, and requirements.
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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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Shanghai Chest Hospital
RECRUITINGShanghai, Xuhui, 200030, China
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- Two-Drug combo takes aim at Hard-to-Treat lung cancer