A Phase 2 interventional study of Serplulimab and Carboplatin in Locally Advanced and Non-small Cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
Drug: Serplulimab · Drug: Carboplatin · Drug: Pemetrexed · Drug: Nab-paclitaxel · Drug: Liposomal paclitaxel · Procedure: Surgery
In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.
Drug: Serplulimab · Drug: Carboplatin · Drug: Pemetrexed · Drug: Nab-paclitaxel · Drug: Liposomal paclitaxel · Radiation: Radiotherapy
In this arm, patients with tumors still unresectable after chemoimmunotherapy will receive therapy in department of medical oncology.
Drug: Serplulimab · Drug: Carboplatin · Drug: Pemetrexed · Drug: Nab-paclitaxel · Drug: Liposomal paclitaxel · Radiation: Radiotherapy
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
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).
Time frame: Up to 30 months
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.
Time frame: Up to 4 months
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
Time frame: up to 5 months
Progression-free survival (PFS)
It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Time frame: up to 60 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).
Time frame: 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.
Time frame: up to 60 months
Duration of response (DOR)
It is defined as the time from the first time of partial response or complete response to progressive disease via RECIST1.1.
Time frame: up to 60 months
Disease-control rate (DCR)
It is defined as the rate of stable disease, partial response, or complete response via RECIST1.1.
Time frame: up to 60 months
R0 rate
It is defined as the rate of complete resection with no residual tumor cell in the resection margin.
Time frame: up to 5 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.
Time frame: 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.
Time frame: up to 5 months
Plan to share: Undecided — The researchers will consider whether IPD is available to other researchers only after the paper is published.
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Shanghai Pulmonary Hospital, Shanghai, China