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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoimmunotherapy | Drug | Induction Serplulimab combined with chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Unresectable stage III (8th TNM) non-small cell lung cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Zhang | Contact | 021-65115006 | zhangpeng1121@tongji.edu.cn | |
| Suyu Wang | Contact | wangsuyv357311854@163.com |
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| Surgery | Procedure | After induction chemoimmunotherapy, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery. |
|
| Radiation | Radiation | After induction chemoimmunotherapy, patients with tumors still unresectable will receive radiotherapy or other therapy. |
|
| Major pathologic response (MPR) |
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery |
| Up to 6 months |
| Disease-free survival (DFS) | It refers to the time (months) from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring). | up to 60 months |
| Overall survival (OS) | It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. | up to 60 months |
| R0 rate | It is defined as the rate of complete resection with no residual tumor cell in the resection margin. | Up to 6 months |
| Severe adverse event (SAE) rate | It is defined as the frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first. | up to 6 months |
| Health related quality of life (HRQol) | The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3). EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality. | up to 6 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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