Not Yet RecruitingPhase 2

Adebrelimab or Retlirafusp Alfa Plus Recaticimab and Chemotherapy for Resectable NSCLC

78 participantsStarted 2026-07

Plain-language summary

Although phase III studies have confirmed the efficacy and safety of perioperative immunotherapy plus chemotherapy for resectable NSCLC, there remains room for improvement in both short-term efficacy and long-term survival. Preclinical evidence suggests that PCSK-9 inhibition may synergize with PD-1 inhibitors to suppress tumor growth in mouse models. To date, no data are available on neoadjuvant PCSK-9 inhibitor therapy combined with immunotherapy and chemotherapy in resectable NSCLC. Therefore, this phase II study aims to evaluate the efficacy and safety of neoadjuvant adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy in patients with resectable NSCLC.

Who can participate

Age range

18 Years – 75 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: * 18-75 years old * Histologically or cytologically confirmed resectable stage II, IIIA, or selected IIIB (T2-3N2bM0 only) non-small cell lung cancer (NSCLC) according to the International Union Against Cancer (UICC) and American Joint Committee on Cancer (AJCC) 9th edition TNM classification for lung cancer, with the tumor judged by the investigator as amenable to curative-intent R0 resection. * Ability to provide tumor tissue specimens, either archived or freshly obtained prior to the first dose of study drug. * Presence of measurable target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST version 1.1. Tumor imaging assessment must be performed within 28 days before the first dose. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * No prior anti-cancer therapy, including radiotherapy, chemotherapy, surgery, or targeted therapy, before study enrollment. * Adequate hematologic and end-organ function. Exclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer (SCLC), mixed SCLC and NSCLC, or other non-NSCLC pathological types. * Known EGFR mutations or ALK positivity, or other actionable driver gene mutations for which approved targeted therapies are available and accessible. * Presence of malignant pleural effusion. For subjects with drainable pleural effusion during the screening period, at least one thoracentesis is required to rule out the presence of mali…

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

pCR rate

Timeframe: four weeks after surgery

Trial details

NCT IDNCT07567326

SponsorPeking University Cancer Hospital & Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials