New combo therapy shows promise for common lung cancer mutation
NCT ID NCT06376084
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study looks at how well the drug osimertinib combined with chemotherapy works as the first treatment for people with advanced EGFR-mutant non-small cell lung cancer. It involves 532 adults with stage IIIB, IIIC, or IV disease who cannot have surgery or radiation. Researchers are tracking how long patients live without the cancer getting worse and how long they live overall in real-world settings.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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532 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
Patients with locally advanced or metastatic, EGFR mutation-positive (Ex19del and/or 21 L858R) NSCLC who receive Osimertinib plus chemotherapy as the first-line therapy based on physician's medical assessment will be enrolled. Approximately 700 patients will be enrolled from about 60 sites in China.
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed. * Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation. * EGFR sensitive mutation-positive (Ex19del and/or 21 L858R) * WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks. * Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months). * Patients with asymptomatic CNS metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed. * Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease. Exclusion Criteria: * Spinal cord compression and symptomatic brain metastases * Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD * Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc * Any banned substance in label
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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.
Contacts and locations
Locations
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Research Site
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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