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A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC

ConditionResectable Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTang-Du Hospital

About this trial

This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles.

Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol

Age ≥ 18 years

Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)

Subjects with Stage IIA (primary focus>4cm), IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8), resectable N2 only refers to non-massive (defined as short diameter less than 3cm), discrete or single station N2 involvement.

Disqualifiers

Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components

Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body

pulmonary sulcus tumor

Contralateral lung nodules, it need biopsy if clinically suspected

Trial design

Design model

Parallel

Treatments tested in this trial

  • sintilimab plus platinum-based chemotherapy

    Drug

    The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy

  • sintilimab plus platinum-based chemotherapy

    Drug

    The subjects in group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab

  • sintilimab plus platinum-based chemotherapy

    Drug

    The subjects in group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: group AExperimental treatment 1 intervention
Group B: group BExperimental treatment 1 intervention
Group C: group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR rate

rate of pathological complete response

Time frame
4 months

Secondary outcomes

1

MPR rate

rate of major pathologic response

Time frame
4 months
2

R0 resectability rate

R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed

Time frame
4 months
3

The completion rate of surgery on schedule

The rate of surgical completion as per the pre-established schedule represents a crucial metric in evaluating the efficiency and precision of medical institutions

Time frame
4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: