RecruitingPhase 2

EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC

China32 participantsStarted 2026-05-21

Plain-language summary

This study is an open-label, multicenter, single-arm clinical study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del/L858R) locally advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th edition of the TNM staging system for lung cancer jointly issued by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC);
. Male or female patients aged ≥ 18 years;
. Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at least two consecutive assessments based on RECIST v1.1 criteria);
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
. At least one measurable or non-measurable but evaluable lesion according to RECIST version 1.1;
. Adequate organ function;
. Female or male patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study period;
. Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements as specified in the visit schedule.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Median Progression-free survival

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Trial details

NCT IDNCT07637448

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-01

View on ClinicalTrials.gov More Lung Cancer Non-Small Cell Cancer (NSCLC) trials