Sugemalimab with chemotherapy before surgery and continued after for resectable stage II–IIIA non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label Phase 2 study enrolling about 25 adults with resectable stage II–IIIA NSCLC without EGFR or ALK mutations and with at least 40% of patients having squamous histology. Participants receive sugemalimab 1200 mg IV every 3 weeks together with platinum-based chemotherapy for 3–4 neoadjuvant cycles, followed by tumor assessment and surgery if there is no progression. Pathological response will be evaluated after surgery, and patients with complete resection will receive adjuvant sugemalimab every 3 weeks for one year. The study primarily monitors feasibility, safety, and signs of anti-tumor activity in the perioperative setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Patients have voluntarily to join the study and give written informed consent for the study.
3. Histologically documented, stage II-IIIA Non-Small Cell Lung Cancer (according to version 9th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated.
4. Tumor should be considered resectable before study entry by a multidisciplinary team.
5. ECOG Performance Status of 0 or 1
6. At least 1 unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
7. Able to comply with study and follow-up procedures
8. Major organ function For regular test results（no blood transfusion within 14 days）：

   1. Hemoglobin（HB）≥90g/L；
   2. Absolute neutrophils count（ANC）≥1.5×109/L；
   3. Blood platelets（PLT）≥100×109/L

   Biochemical tests results defined as follows:
   1. Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
   2. Alanine aminotransferase (ALT) and aspartate aminotransgerase AST≤2.5\*ULN,
   3. Creatinine（Cr）≤1.5\*ULN or Creatinine Clearance rate (CCr)≥60 ml/min; Coagulation test: INR/APTT within normal limits Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value (50%).
9. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
10. Subjects must provide fresh tissues or formalin-fixed tumor tissue samples at or the diagnosis NSCLC for mIF.

Exclusion Criteria:

* 1\) All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.

  2\) Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).

  3\) Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy 4) Severe acute or chronic infections, including: hepatits B, hepatits C, HIV etc 5) Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.

  6\) Histologically confirmed adenosquamous carcinoma 7) Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins 8) Subjects have interstitial lung disease (ILD), or a history of ILD that required corticosteroid treatment.

  9\) Women in pregnancy or lactation. 10) Patients who are allergic to any of the agent or any ingredient

Where it's running

• Shanghai Pulmonary Hospital, Shanghai, China
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: shengxiang ren Ren, Pro.
• Email: harry_ren@126.com
• Phone: 13816756732

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Understanding what patients want from NSCLC treatment monitoring

  Researchers are testing how patients with non-small cell lung cancer feel about and prefer monitoring their symptoms during treatment, with input from patients, caregivers, and clinicians.

  Recruiting European Institute of Oncology · Milan, mI · NCT07909343

• PD-L1-targeted PET probe to map PD-L1 in solid tumors

  A PET tracer called 18F-F-PDL1-3 is being tested to see if it can detect PD-L1 expression in primary and metastatic tumors to help guide personalized treatment.

  Recruiting Phase 2 Peking University Cancer Hospital & Institute · Beijing · NCT07848243

• Cardiorespiratory fitness after lobectomy versus sublobar resection in NSCLC

  This study tests how different lung surgeries (lobectomy vs. sublobar resection) affect fitness levels after surgery in people with non-small cell lung cancer.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07841249

• CAIX-targeted PET/CT imaging in solid tumors

  Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.

  Recruiting Zhongnan Hospital · Wuhan, Hubei · NCT07833085

• NUT Project: Nutritional Support in Thoracic Cancer

  We’ll see if providing tailored nutrition guidance and assessment helps people with advanced lung cancer during their treatment.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07817329

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.