Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Specified dose on specified days Sintilimab

Biological: Sintilimab Drug: Cisplatin Drug: Paclitaxel for Injection (Albumin Bound) Drug: Carboplatin

YANG SONG, MD

The purpose of this study is to determine the feasibility and evaluate the safety of delivering chemotherapy, the usual approach to non-small cell lung cancer, in combination with Sintilimab (PD-1 antibody), followed by adjuvant therapy after surgical resection. Consolidation therapy is treatment given following the initial treatment.

Sintilimab is an investigational drug, which has been approved by the NMPA(National Medical Products Administration,China. https://www.nmpa.gov.cn/) for use in late stage of non-small cell lung cancer (NSCLC). Sintilimab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.

The primary hypothesis is that the addition of Sintilimab to neoadjuvant concurrent chemotherapy, followed by consolidation Sintilimab, will be safe and feasible to deliver to patients with resectable stage 3A Non-small cell lung cancer (NSCLC).

This study also plans to observe the efficacy of this combination in the overall and biomarker-positive population.

Study Design This is an open-label, single arm phase III trial of neoadjuvant chemotherapy + Sintilimab with concurrent radiation followed by surgical resection and consolidation Sintilimab in resectable stage 3A (N2+) NSCLC.

Eligible patients will have biopsy-confirmed T1-3N2M0 (stage IIIA) non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC not otherwise specified), performance status 0-1, adequate lung function and deemed medically resectable by a thoracic surgeon, adequate organ function for chemotherapy, and no contraindications to Sintilimab (i.e. autoimmune disorders or underlying pulmonary fibrosis).

Sintilimab Plus Paclitaxel (Albumin Bound) and Platinum Doublet Chemotherapy in Stage of IIIA NSCLC, as the Neoadjuvant treatment.

this is a single-arm study, masking is not require.

A Neoadjuvant Study of Sintilimab Plus Platinum Doublet Chemotherapy in IIIA(N2) Stage NSCLC

A Neoadjuvant Study of Sintilimab Plus Platinum Doublet Chemotherapy in IIIA(N2) Stage Non-Small Cell Lung Cancer (NSCLC)

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Proportion of patients with complete tumor removal (R0 resection)

Pathological complete response is defined as absence of foci of tumor cells at the local site (pCR)

The major pathologic response to preoperative therapy, defined histopathologically by the presence of less than 5% viable cancer cells in the surgical specimen, is an important prognostic factor for patients with NSCLC. In this study, we will calculate the proportion of patients with Major Pathologic Responses.

the proportion of patients with disappearance of all signs of cancer in response to treatment. Also called complete response rate.

Time from beginning of treatment to progression, death, or five years, whichever came first. Progression is defined as Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the OS is one way to see how well a new treatment works.

Spots Global Cancer Trial Database for biological: sintilimab drug: cisplatin drug: paclitaxel for injection (albumin bound) drug: carboplatin