Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

NCT05766800 | Recruiting Phase 2

• 1 other identifier: LungMate-013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.

Conditions

Locally Advanced; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  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 30 months

Secondary Outcomes (10)

• Objective response rate (ORR)

  Up to 4 months

• Major pathologic response (MPR)

  up to 5 months

• Progression-free survival (PFS)

  up to 60 months

• Disease-free survival (DFS)

  up to 60 months

• Overall survival (OS)

  up to 60 months

Study Arms (3)

Downstaged arm with surgical treatment

EXPERIMENTAL

In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.

Drug: Serplulimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab-paclitaxel; Drug: Liposomal paclitaxel; Procedure: Surgery

Downstaged arm with radiotherapy

ACTIVE COMPARATOR

In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.

Drug: Serplulimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab-paclitaxel; Drug: Liposomal paclitaxel; Radiation: Radiotherapy

Unresectable arm

OTHER

In this arm, patients with tumors still unresectable after chemoimmunotherapy will receive therapy in department of medical oncology.

Drug: Serplulimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab-paclitaxel; Drug: Liposomal paclitaxel; Radiation: Radiotherapy

Interventions

Serplulimab DRUG

Specified dose on specified days

Downstaged arm with radiotherapy; Downstaged arm with surgical treatment; Unresectable arm

Carboplatin DRUG

Specified dose on specified days

Downstaged arm with radiotherapy; Downstaged arm with surgical treatment; Unresectable arm

Pemetrexed DRUG

Specified dose on specified days

Downstaged arm with radiotherapy; Downstaged arm with surgical treatment; Unresectable arm

Nab-paclitaxel DRUG

Specified dose on specified days

Downstaged arm with radiotherapy; Downstaged arm with surgical treatment; Unresectable arm

Liposomal paclitaxel DRUG

Specified dose on specified days

Downstaged arm with radiotherapy; Downstaged arm with surgical treatment; Unresectable arm

Surgery PROCEDURE

Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.

Downstaged arm with surgical treatment

Radiotherapy RADIATION

Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.

Downstaged arm with radiotherapy; Unresectable arm

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 IIIB-IIIC 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 normal 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 Serplulimab (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 Serplulimab (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, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

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

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; Therapeutics

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: February 28, 2023
• First Posted: March 13, 2023
• Study Start: March 14, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)