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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Enrolling; Phase 2

Conditions: Locally Advanced; Non-small Cell Lung Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05766800

LungMate-013

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

Downstaged arm with surgical treatment

Experimental group

Description:

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

Treatment:

Procedure: Surgery

Drug: Pemetrexed

Drug: Liposomal paclitaxel

Drug: Nab-paclitaxel

Drug: Serplulimab

Drug: Carboplatin

Downstaged arm with radiotherapy

Active Comparator group

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: Pemetrexed

Drug: Liposomal paclitaxel

Drug: Nab-paclitaxel

Drug: Serplulimab

Drug: Carboplatin

Unresectable arm

Other group

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: Pemetrexed

Drug: Liposomal paclitaxel

Drug: Nab-paclitaxel

Drug: Serplulimab

Drug: Carboplatin