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

Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients

This study will test whether giving sugemalimab with chemotherapy before surgery and continuing sugemalimab after surgery helps adults with resectable stage II–IIIA non-small cell lung cancer who do not have EGFR or ALK mutations.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (other)
• Drugs / interventions: chemotherapy, immunotherapy, Sugemalimab, suglizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06987734 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with treatment-naive, resectable stage II–IIIA NSCLC, ECOG 0–1, measurable disease, adequate organ function, no EGFR/ALK mutations, and willingness to undergo perioperative treatment and follow-up.

Not a fit: Patients with EGFR or ALK mutations, unresectable disease, poor performance status, major organ dysfunction, or those who progress during neoadjuvant therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase tumor shrinkage before surgery and lower the risk of cancer returning after surgery, potentially improving cure rates for resectable NSCLC.

How similar studies have performed: Other trials combining PD-1/PD-L1 immunotherapy with neoadjuvant chemotherapy in resectable NSCLC have shown promising pathological response rates and improved outcomes, though sugemalimab specifically is less well studied in this exact perioperative setting.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Pulmonary Hospital, Shanghai, China — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: shengxiang ren Ren, Pro.

Conditions: Lung Cancer, Neoadjuvant, NSCLC, immunotherapy, adjuvant