Induction Therapy With Serplulimab Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer

NCT06591910 | Not Yet Recruiting

• 1 other identifier: LungMate-Unresectable
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

For unresectable stage III (8th TNM) non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether induction chemoimmunotherapy followed by surgery or radiotherapy can provide good survival for this population. This prospective observational study aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery/radiotherapy.

Conditions

Unresectable Stage III Non-small-cell Lung Cancer

Keywords

unresectable; stage III; non-small cell lung cancer; chemoimmunotherapy

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 60 months

Secondary Outcomes (7)

• Objective response rate (ORR)

  Up to 6 months

• Major pathologic response (MPR)

  Up to 6 months

• Disease-free survival (DFS)

  up to 60 months

• Overall survival (OS)

  up to 60 months

• R0 rate

  Up to 6 months

Study Arms (1)

Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC

Drug: Chemoimmunotherapy; Procedure: Surgery; Radiation: Radiation

Interventions

Chemoimmunotherapy DRUG

Induction Serplulimab combined with chemotherapy

Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC

Surgery PROCEDURE

After induction chemoimmunotherapy, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.

Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC

Radiation RADIATION

After induction chemoimmunotherapy, patients with tumors still unresectable will receive radiotherapy or other therapy.

Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC

Eligibility Criteria

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

Study Population

Unresectable stage III (8th TNM) non-small cell lung cancer

You may qualify if:

• The patient shall sign the Informed Consent Form.
• Aged 18 ≥ years.
• Histological or cytological diagnosis of unresectable NSCLC by needle biopsy, and stage III (8th TNM) 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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative; Radiation

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)

Physical Phenomena

Central Study Contacts

Peng Zhang

CONTACT

021-65115006; zhangpeng1121@tongji.edu.cn

Suyu Wang

CONTACT

wangsuyv357311854@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09