Toripalimab Combined With Double Platinum-based Chemotherapy for Initially Unresectable NSCLC

NCT04144608 | Completed Phase 2

• 1 other identifier: TOGATHER
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to investigate the efficacy of Toripalimab Combined with Double Platinum Based Chemotherapy for Initially Unresectable Non-driver Gene Mutation Non-small Cell Lung Cancer.

Conditions

Advanced Non Small Cell Lung Cancer

Keywords

Toripalimab NSCLC

Outcome Measures

Primary Outcomes (1)

• R0 surgical resection rate

  No residual ratio under the microscope after surgical resection

  Approximately 1 years

Secondary Outcomes (6)

• ORR

  Approximately 2 years

• Major Pathological Response (MPR) rate

  Approximately 2 years

• Complete Response (pCR) rate

  Approximately 2 years

• Event-Free Survival (EFS)

  Approximately 2 years

• Disease-Free Survival (DFS)

  Approximately 2 years

Study Arms (1)

Toripalimab Combined With Platinum-containing Dual-agent

EXPERIMENTAL

Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer

Drug: Toripalimab

Interventions

Toripalimab DRUG

Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1

Also known as: platinum-based chemotherapy

Toripalimab Combined With Platinum-containing Dual-agent

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have fully understood the trial and are willing to sign the informed consent form.
• Ages between 18 years old to 70 years old, with no gender restrictions.
• Previously untreated, histologically confirmed, potentially resectable stage IIIA-IIIB NSCLC (AJCC staging 8th edition); potentially resectable refers to patients with T3 or T4 primary lesions and positive N1 or N2 lymph nodes who are expected to be difficult to resect or require pneumonectomy after discussion by MDT (including surgery, imaging, anesthesia, and internal medicine).
• Measurable lesions according to Response Evaluation Criteria in Solid Tumors Version 1.1.
• Before enrollment, 20 tissue sections (thickness 4-6 microns) must be submitted for biomarker evaluation (tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment; fresh tissue must be core needle biopsy, excision, or incision biopsy specimens).
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• Good organ function:
• Hematology: absolute neutrophil count (ANC) ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 9.0g/dL or ≥ 5.6 mmol/L;
• Kidney: serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cock-Gault formula);
• Liver: Total bilirubin ≤ 1.5 × ULN or direct bilirubin within normal limits for subjects with total bilirubin levels \> 1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN;
• Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for subjects who are receiving anticoagulant therapy, as long as PT or aPTT is within the intended use range of the anticoagulant drug; (1)Cardiac function test: Baseline electrocardiogram shows no PR interval prolongation or atrioventricular block;
• Total lung function is adequate to sustain the planned lung resection, as assessed by the surgeon.
• Women must agree to use contraceptive measures (such as intrauterine devices (IUDs), birth control pills or condoms) during the study and within 6 months after the study ends; serum or urine pregnancy tests must be negative within 7 days before study enrollment, and must not be breastfeeding patients; men must agree to use contraceptive measures during the study and within 6 months after the study ends.

You may not qualify if:

• Histopathological identification is neuroendocrine carcinoma or sarcomatoid tumor.
• Resectable disease in the early stage.
• Subjects with known EGFR mutations or ALK, ROS1 translocations, and subjects with non-squamous cell carcinoma need to clarify the EGFR, ALK and ROS1 mutation status.
• Early-stage NSCLC who have received prior systemic anticancer therapy, including investigational drugs.
• History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids, or current pneumonitis/interstitial lung disease requiring steroids.
• Known history of active tuberculosis.
• Known active infection requiring systemic therapy.
• Subjects with any known or suspected autoimmune disease or immunodeficiency, except patients with a history of hypothyroidism who do not require hormone therapy or are receiving physiological doses of hormone replacement therapy; subjects with stable type 1 diabetes with controlled blood glucose.
• Subjects with active hepatitis B (defined as a positive result of hepatitis B virus surface antigen \[HBsAg\] test during the screening period and a HBV-DNA test value higher than the upper limit of the normal value of the laboratory department of the research center) or hepatitis C (defined as a positive result of hepatitis C virus surface antibody \[HCsAb\] test during the screening period and a positive HCV-RNA test result).
• Known human immunodeficiency virus (HIV) infection (known HIV antibody positive).
• Live vaccines within 30 days prior to first dose. Including but not limited to the following: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines (inactivated virus vaccines are permitted).
• Have grade ≥ 2 peripheral neuropathy.
• Patients who have received previous treatment with PD-1/PD-L1 drugs or another drug targeting T cell receptors (e.g. CTLA-4, OX-40, etc.).
• Patients with any severe and/or uncontrolled illness:
• (1)patients with unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; patients with poorly controlled blood pressure (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);.

Sponsors & Collaborators

• Yongchang Zhang: lead

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• Zeng L, Yan H, Jiang W, Qin H, Dai J, Zhang Y, Wei S, Chen S, Liu L, Xiong Y, Yang H, Li Y, Wang Z, Deng L, Xu Q, Peng L, Zhang R, Fang C, Chen X, Deng J, Wang J, Li T, Liu H, Zhang G, Yang N, Zhang Y. Toripalimab plus platinum-doublet chemotherapy as perioperative therapy for initially unresectable NSCLC: An open-label, phase 2 trial. Med. 2025 Jun 13;6(6):100574. doi: 10.1016/j.medj.2025.100574. Epub 2025 Jan 31.

  PMID: 39892382 DERIVED

MeSH Terms

Interventions

toripalimab; Platinum Compounds

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Yongchang Z MD, MD

  Hunan Province Tumor Hospital

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: January 16, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)