An observational study in Unresectable Stage III Non-small-cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 50 is below the median of 189 across 1,514 observational 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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Unresectable stage III (8th TNM) non-small cell lung cancer
Exclusion Criteria:
Drug: Chemoimmunotherapy · Procedure: Surgery · Radiation: Radiation
Induction Serplulimab combined with chemotherapy
After induction chemoimmunotherapy, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
After induction chemoimmunotherapy, patients with tumors still unresectable will receive radiotherapy or other therapy.
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 60 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 6 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 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).
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
R0 rate
It is defined as the rate of complete resection with no residual tumor cell in the resection margin.
Time frame: 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.
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 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Pulmonary Hospital, Shanghai, China