Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC

NCT05400070 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: K202104-03
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.

Conditions

Sintilimab; Lung Cancer; Anlotinib; Chemotherapy

Keywords

Sintilimab, Anlotinib. chemotherapy. safety. efficacy

Outcome Measures

Primary Outcomes (1)

• pathological complete response (PCR)

  pathological complete response (PCR)

  up to 4 months

Study Arms (1)

neoadjuvant therapy

EXPERIMENTAL

Sintilimab (200mg fixed dose) iv, d1, q3w，anlotinib 10mg, po, qd1-14, q3w combine with Chemotherapy

Drug: Neoadjuvant therapy 1

Interventions

Neoadjuvant therapy 1 DRUG

Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.

Also known as: anlotinib 10mg, po, qd1-14, q3w, Chemotherapy, Sintilimab (200mg fixed dose) iv, d1, q3w

neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathological diagnosis of lung cancer, Age 18 years and 75 years old, physical strength status score 0-1;
• The investigator believes that the subject can comply with the study protocol;
• The investigator has confirmed to have at least one measurable lesion according to the RECIST1.1 criteria;
• Stage IIA, IIB, IIIA, IIIB NSCLC with histological or cytology proven operable treatment according to the International Association for Lung Cancer Research and the American Joint Committee on Cancer Staging version 8;
• Good hematopoietic function, defined as absolute neutrophil number 1.5X109 / L (no granulocyte colony stimulating factor support therapy), platelet count 100X109 / L, hemoglobin 90 g / L; (no transfusion or no erythropoietin dependence within 7 days);
• Good liver function, defined as 1.5 times the normal limit (ULN) of serum total bilirubin; ULN at 2.5 times transaminase (AST) and ALT); AST and ALT for recorded ULN;
• Good renal function, defined as serum creatinine 1.5 times ULN or calculated creatinine clearance of 60 ml/min (Cockcroft-Gault formula); routine urine protein less than 2 +, or 24h urine protein \<1g;
• Good coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) 1.5 times ULN;
• The total amount of lung function (e. g., FVC, FEV1, TLC, FRC, and DLco) can tolerate the proposed lung resection procedure;
• For female subjects of childbearing age, the urine or serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1)

You may not qualify if:

• Presof locally advanced unresectable or metastatic disease;
• peripheral neuropathy;
• Active, known or suspected autoimmune diseases, type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur without external stimulus factors can be selected;
• \. Systemic treatment with corticosteroids (an equivalent dose of\> 10 mg prednisone per day) or other immunosuppressive drugs within 14 days before randomization.Inhalor topical steroids are permitted without active autoimmune disease.
• Active Hepatitis B / hepatitis C infection and known HIV;
• Patients who have previously received chemotherapy or any other anti-tumor therapy;

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital, the Air Force Military University

Xi'an, 710038, China

Location

Related Publications (1)

• Duan H, Shao C, Luo Z, Wang T, Tong L, Liu H, Yao X, Lei J, Zhao J, Gao Y, Jiang T, Yan X. Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial). Signal Transduct Target Ther. 2024 Oct 28;9(1):296. doi: 10.1038/s41392-024-01992-0.

  PMID: 39465257 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

anlotinib; Drug Therapy; sintilimab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

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

Model Details: Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 1, 2022
• Study Start: March 1, 2021
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)