Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC

NCT07819578 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-FXY-019-NEIKE
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter, single-arm Phase II investigator-initiated trial evaluating neoadjuvant toripalimab plus sacituzumab tirumotecan (SKB264) in treatment-naive adults with resectable or potentially resectable, driver-negative non-small cell lung cancer (NSCLC). Eligible participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2) and will receive sacituzumab tirumotecan 5 mg/kg plus toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles. Participants deemed operable after multidisciplinary assessment will undergo definitive surgery. The primary endpoint is pathologic complete response. A Simon two-stage minimax design plans to enroll 30 participants.

Conditions

Non-Small Cell Lung Cancer

Keywords

Toripalimab; Sacituzumab Tirumotecan; NSCLC; Resectable NSCLC; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  Proportion of participants with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes. Participants without surgery or evaluable surgical pathology will be counted as non-pCR.

  At definitive surgery, up to 18 weeks after first study treatment

Secondary Outcomes (7)

• Major Pathological Response (MPR) Rate

  At definitive surgery, up to 18 weeks after first study treatment

• R0 Resection Rate

  At definitive surgery, up to 18 weeks after first study treatment

• Pathological Downstaging Rate

  At definitive surgery, up to 18 weeks after first study treatment

• Objective Response Rate (ORR)

  Up to 18 weeks after first study treatment

• Event-Free Survival (EFS)

  Up to 60 months from enrollment

Study Arms (1)

Toripalimab plus sacituzumab tirumotecan

EXPERIMENTAL

Participants will receive sacituzumab tirumotecan 5 mg/kg intravenously on Day 1 every 2 weeks combined with toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy. Surgery will be performed after multidisciplinary assessment when appropriate. Postoperative or adjuvant treatment will be determined according to guidelines and investigator assessment.

Drug: Toripalimab; Drug: Sacituzumab Tirumotecan (SKB264)

Interventions

Toripalimab DRUG

Toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with sacituzumab tirumotecan.

Toripalimab plus sacituzumab tirumotecan

Sacituzumab Tirumotecan (SKB264) DRUG

Sacituzumab tirumotecan (SKB264) 5 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with toripalimab.

Toripalimab plus sacituzumab tirumotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained before any study procedure.
• Age 18 to 75 years, male or female.
• Histologically/cytologically confirmed, treatment-naive, resectable or potentially resectable NSCLC: stage II-IIIA and selected IIIB (T3N2, T4N2) per IASLC/UICC TNM 9th edition.
• Disease staged as cTNM by PET-CT or by neck/chest/abdominal/pelvic CT plus whole-body bone scan and brain MRI.
• Multidisciplinary team including thoracic surgeon judges lesion resectable or potentially resectable.
• At least one measurable target lesion per RECIST 1.1.
• ECOG performance status 0-1.
• Adequate organ function (baseline, no transfusion, rh-EPO, or G-CSF within 2 weeks before first dose): neutrophils ≥1.5 ×10\^9/L; platelets ≥100 ×10\^9/L; hemoglobin ≥9 g/dL.
• AST, ALT, ALP ≤2.5 × ULN; TBil ≤1.5 × ULN.
• For liver metastases: AST/ALT ≤5 × ULN; TBil ≤2 × ULN.
• For liver or bone metastases: ALP ≤5 × ULN.
• Creatinine clearance (Cockcroft-Gault) ≥60 mL/min.
• INR, APTT, PT ≤1.5 × ULN.
• TSH within normal range; if TSH abnormal but T3 and free T4 normal, eligible.
• Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and use effective contraception during treatment and until 12 months after last dose; men with partners of childbearing potential must use effective contraception during treatment and until 12 months after last dose.

You may not qualify if:

• Neuroendocrine histology component in tumor pathology.
• Known EGFR sensitizing mutation or ALK fusion (for non-squamous NSCLC, EGFR/ALK status must be determined).
• Other malignancy within 5 years, except those with clinically negligible metastatic risk and curative treatment intent (e.g., adequately treated carcinoma in situ as per protocol examples).
• Severe or uncontrolled comorbidities, including symptomatic cerebrovascular events or liver disease at Child-Pugh grade ≥A.
• History of allogeneic stem cell transplantation or solid organ transplantation.
• Severe dry eye syndrome, severe meibomian gland dysfunction, severe blepharitis, or corneal disorders that may delay corneal healing.
• History of interstitial lung disease requiring steroids, or active ILD.
• HIV positive or diagnosed AIDS.
• Active tuberculosis.
• Active HCV infection (HCV antibody positive and HCV RNA positive).
• Known hypersensitivity to toripalimab or sacituzumab tirumotecan (or excipients).
• Live vaccine within 30 days before first dose (except inactivated vaccines allowed where specified by protocol, including local policy).
• Any systemic or local anticancer treatment before first study treatment.
• Use of traditional Chinese medicines with anticancer indication within 7 days before first dose, or need to continue such drugs during study.
• Other investigational drug not discontinued for at least 5 half-lives or 2 months (whichever is longer) before first dose.

Sponsors & Collaborators

• Shaodong Hong: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shaodong Hong Hong, M.D., Ph.D.

CONTACT

+8615920527656; hongshd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Inverstigator

Model Details: Neoadjuvant toripalimab plus sacituzumab tirumotecan for resectable driver-negative NSCLC.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share