Combining immunotherapy and chemotherapy for advanced lung cancer treatment

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial

This study is testing a new treatment that combines immunotherapy with chemotherapy to see if it can help people with advanced lung cancer turn their tumors into ones that can be surgically removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: Serplulimab, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT05766800 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of a treatment regimen that combines a PD-1 antibody with platinum-based chemotherapy for patients with unresectable locally advanced non-small cell lung cancer. The study aims to determine if this combination therapy can convert initially unresectable tumors into resectable ones, potentially allowing for surgical intervention. Participants will receive serplulimab along with carboplatin, pemetrexed, nab-paclitaxel, and liposomal paclitaxel. The trial will assess both the therapeutic outcomes and the safety profile of this approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage IIIB-IIIC non-small cell lung cancer who have not yet undergone surgery.

Not a fit: Patients with systematic metastasis or those who are not able to tolerate surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced lung cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of immunotherapy and chemotherapy, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with normal lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. 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.
11. 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).

Exclusion Criteria:

1. 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;
2. 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;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.

Where this trial is running

Shanghai

• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Peng Zhang, PhD

Conditions Locally Advanced; Non-small Cell Lung Cancer