Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer

NCT06109402 | Not Yet Recruiting Phase 2

• 1 other identifier: LungMate-019
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.

Conditions

Stage II-IIIB(N2) Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year event-free survival (EFS) rate

  Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

  Up to 48 months

Secondary Outcomes (9)

• Objective response rate (ORR)

  Up to 6 months

• Pathological complete response (pCR)

  Up to 8 months

• Major pathologic response (MPR)

  Up to 8 months

• Event-free survival (EFS)

  Up to 72 months

• Overall survival (OS)

  Up to 72 months

Study Arms (2)

Perioperative immunotherapy

EXPERIMENTAL

In this arm, patients will receive neoadjuvant immunochemotherapy and adjuvant immunotherapy.

Drug: TQB2450; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab-paclitaxel; Procedure: Surgery

Adjuvant immunotherapy

EXPERIMENTAL

In this arm, patients will receive adjuvant immunochemothrapy and immunotherapy

Drug: TQB2450; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab-paclitaxel; Procedure: Surgery

Interventions

TQB2450 DRUG

Specified dose on specified days

Adjuvant immunotherapy; Perioperative immunotherapy

Carboplatin DRUG

Specified dose on specified days

Adjuvant immunotherapy; Perioperative immunotherapy

Pemetrexed DRUG

Specified dose on specified days

Adjuvant immunotherapy; Perioperative immunotherapy

Nab-paclitaxel DRUG

Specified dose on specified days

Adjuvant immunotherapy; Perioperative immunotherapy

Surgery PROCEDURE

Surgery for II-IIIB (N2) non-small cell lung cancer

Adjuvant immunotherapy; Perioperative immunotherapy

Eligibility Criteria

• Age: 18 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 II-IIIB (N2) 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.
• Patients with good function of other main organs (liver, kidney, blood system, etc.)
• Patients with lung function can tolerate surgery;
• Without systematic metastasis (including M1a, M1b and M1c);
• Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
• Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later).

You may not qualify if:

• 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;
• 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;
• Participants who are allergic to the test drug or any auxiliary materials;
• Participants with Interstitial lung disease currently;
• Participants with active hepatitis B, hepatitis C or HIV;
• Pregnant or lactating women;
• Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
• Participated in another therapeutic clinical study;
• Other factors that researchers think it is not suitable for enrollment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Pemetrexed; 130-nm albumin-bound paclitaxel; Surgical Procedures, Operative

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)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Peng Zhang, PhD

CONTACT

02165115006; zhangpeng1121@tongji.edu.cn

Suyu Wang

CONTACT

wangsuyv357311854@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CN (1)