Can removing the main tumor boost targeted therapy in advanced lung cancer?
NCT ID NCT07177092
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 starting the targeted drug osimertinib can help people with advanced EGFR-mutant non-small cell lung cancer. About 118 patients with stage III-IV cancer will be randomly assigned to get surgery plus osimertinib or osimertinib alone. The goal is to see if the combination delays cancer progression and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Osimertinib (a targeted therapy pill) and surgery to remove the main lung tumor
- What this could lead to
- If successful, this could show that combining surgery with targeted therapy helps people with advanced EGFR-mutant lung cancer live longer without their disease getting worse.
- What could go wrong
- This is a small, early-phase (phase 2) study with only 118 people. Surgery in advanced cancer carries risks like infection or complications, and the added benefit over osimertinib alone 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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Dec 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 restriction on sex. 2. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, unresectable as assessed by multidisciplinary team (MDT). 3. Presence of EGFR exon 19 deletion (19Del) or L858R mutation, confirmed by ARMS-PCR, NGS, or other validated methods. 4. No prior systemic therapy for lung cancer. 5. ECOG performance status of 0-1. 6. Estimated life expectancy of at least 6 months. 7. Primary lung tumor size ≥1 cm, with at least one measurable lesion remaining after resection according to RECIST v1.1 criteria. 8. Adequate organ function, including: ① Hematologic function: absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥9.0 g/dL. ② Hepatic function: ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases are present); total bilirubin ≤1.5 × ULN. ③ Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula). 9. Adequate pulmonary function (must meet at least one of the following to ensure postoperative reserve): ① FEV1 ≥1.2 L (or ≥40% of predicted value); ② FEV1/FVC ≥0.7, to exclude severe obstructive ventilatory dysfunction; 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%, additional cardiopulmonary exercise testing (e.g., 6-minute walk test, stair climbing test) is recommended to evaluate postoperative pulmonary reserve. 10. Evaluated by the study team and deemed suitable for primary tumor resection. 11. Signed written informed consent and willingness to comply with study protocol. Exclusion Criteria: 1. Presence of any other known EGFR mutations. 2. Histological evidence of mixed small-cell lung cancer (SCLC) or history of transformation to SCLC. 3. Immunodeficiency: history of primary immunodeficiency disorders, or prior allogeneic organ or bone marrow transplantation. 4. Active brain metastases. Patients with adequately treated brain metastases may be eligible if they are neurologically stable for at least 2 weeks before enrollment, and are either not requiring corticosteroids or receiving a stable or decreasing dose of ≤10 mg prednisone (or equivalent) once daily. 5. Pregnancy. 6. Any serious comorbid condition that, in the opinion of the investigator, may interfere with participation in the study or interpretation of study results, including but not limited to: uncontrolled systemic diseases, psychiatric illness, active or uncontrolled infections, or other abnormal findings from laboratory or clinical examinations.
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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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