Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

NCT04728724 | Recruiting Phase 2

• 1 other identifier: LungMate-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR)

  MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery

  up to 5 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  up to 4 months

• Disease-free survival (DFS)

  up to 60 months

• Progression-free survival (PFS)

  up to 60 months

• Overall survival (OS)

  up to 60 months

• Safety: frequency of severe adverse events

  up to 6 months

Study Arms (2)

Group A

EXPERIMENTAL

Anti-PD-1 monotherapy

Drug: Sintilimab

Group B

EXPERIMENTAL

Anti-PD-1 plus chemotherapy

Drug: Sintilimab; Drug: Chemotherapy

Interventions

Sintilimab DRUG

Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.

Group A; Group B

Chemotherapy DRUG

Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Non-squamus: Carboplatin AUC 5 + Pemetrexed 500mg/m2; Squamous: Carboplatin AUC 5 + Gemcitabine 1000mg/m2 or Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.

Group B

Eligibility Criteria

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

You may qualify if:

• The patient shall sign the Informed Consent Form.
• Aged 18 ≥ years.
• Histological or cytological diagnosis of NSCLC by needle biopsy, and stage III confirmed by imageological examinations (CT, PET-CT or EBUS).
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
• Life expectancy is at least 12 weeks.
• At least 1 measurable lesion according to RECIST 1.1.
• With the feasiblility or anticipated feasiblility after neoadjuvant therapy to receive radical surgery;
• Patients with good function of other main organs (liver, kidney, blood system, etc.):
• ANC count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L，hemoglobin ≥90 g/L;
• the international standard ratio of prothrombin time (INR) and prothrombin time (PT) \< 1.5 times of upper limit of normal (ULN);
• Partial thromboplastin time (APTT) ≤1.5×ULN;
• Total bilirubin ≤1.5×ULN;
• Alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.
• Patients with normal lung function can tolerate surgery;
• Without systematic metastasis (including M1a, M1b and M1c);

You may not qualify if:

• Non-squamous cell carcinoma with EGFR active mutation positive or ALK rearrangement;
• Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
• Administration of any Chinese medicine against cancer before administration of the drug;
• Participants with other cancer (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor \[including TA and tis\]) within five years before the start of this study;
• Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
• With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
• Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
• Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \>10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
• Participants who are allergic to the test drug or any auxiliary materials;
• Participants with active hepatitis B, hepatitis C or HIV;
• The vaccine was administered within 4 weeks of the start of the trial;
• Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial;
• The patients have active pia meningioma, uncontrolled or untreated brain metastases;
• Pregnant or lactating women;
• Participants suffering from nervous system diseases or mental diseases that cannot cooperate;

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic department

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: September 10, 2022
• Primary Completion: September 15, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)