Surgery before chemo and immunotherapy may boost lung cancer outcomes
NCT ID NCT07177105
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study looks at whether surgically removing the primary lung tumor before giving immunotherapy (sintilimab) and chemotherapy can improve outcomes for people with advanced non-small cell lung cancer that is not driven by EGFR or ALK mutations. About 118 participants will be randomly assigned to either receive surgery followed by the drug combination, or the drugs alone. The main goal is to see if the surgery helps delay cancer progression or improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab, pemetrexed, carboplatin, and cytoreductive surgery
- What this could lead to
- If successful, this could show that removing the primary tumor before immunotherapy and chemotherapy helps people with advanced lung cancer live longer without their disease getting worse.
- What could go wrong
- This is a Phase 2 trial with only 118 participants, so results are preliminary. Surgery in advanced cancer carries risks like infection or complications, and the added benefit over standard treatment is not yet proven.
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 118 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
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 to 75 years
- 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 18-75 years, no sex limitation; 2. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, deemed unresectable (evaluated by MDT); 3. Negative for EGFR mutation and ALK rearrangement (tested by ARMS-PCR, NGS, or equivalent methods); 4. No histological evidence of small cell lung cancer (SCLC) or transformation to SCLC; 5. No prior exposure to anti-tumor therapy; 6. ECOG performance status of 0-1; 7. Expected survival ≥ 6 months; 8. Primary tumor diameter ≥ 1 cm, with at least one measurable lesion remaining after resection (per RECIST v1.1 criteria); 9. Adequate major organ function, including: ① Hematologic: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9.0 g/dL; ② Hepatic: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN in case of liver metastases), total bilirubin ≤ 1.5 × ULN; * Renal: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula); 10. Pulmonary function (patients must meet at least one of the following to ensure adequate postoperative pulmonary reserve): ① FEV1 ≥ 1.2 L (or ≥ 40% of predicted value); ② FEV1/FVC ≥ 0.7, excluding severe obstructive ventilatory impairment; ③ DLCO (diffusing capacity for carbon monoxide) ≥ 40% of predicted value, to assess diffusion capacity; ④ If preoperative FEV1 \< 1.2 L or DLCO \< 40%, a quantitative perfusion scan is recommended along with preoperative exercise testing (e.g., 6-minute walk test, stair-climbing test) to evaluate residual pulmonary function; 11. Preoperative assessment by the study team confirming that the patient can tolerate primary lesion resection; 12. Signed informed consent with willingness to comply with study protocol. Exclusion Criteria: 1. Impaired immune function: history of primary immunodeficiency; history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 2. Active brain metastases. Patients with adequately treated brain metastases may be eligible if they have remained neurologically stable for at least 2 weeks prior to study entry and are not receiving systemic corticosteroids or are on a stable/reducing dose equivalent to ≤10 mg prednisone daily. 3. Pregnancy. 4. Presence of any severe, uncontrolled, or unstable comorbidity that, in the opinion of the investigator, may interfere with the patient's participation in the study or affect the interpretation of study results, including uncontrolled seizures, psychiatric disorders, active or uncontrolled infections, or other conditions (including laboratory abnormalities).
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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 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.
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