Non Small Cell Lung Cancer Stage III, Small-Cell Lung Cancer
Conditions
Brief summary
PACIFIC-PUMCH-R is an ambispective cohort study that will enroll approximately 100 patients with lung cancer who have received at least one dose of durvalumab between July 2020 and July 2021. Patient selection and data collection will be from Peking Union Medical College Hospital. Cohort 1 will include patients with unresectable stage III non-small cell lung cancer (according to the Staging Manual in Thoracic Oncology, version 7, of the International Association for the Study of Lung Cancer) who did not have disease progression after concurrent chemoradiotherapy. The primary objective of Cohort 1 is to assess the effectiveness of durvalumab in a real-life setting by evaluating PFS and OS in Chinese patients. Cohort 2 will enroll patients with histologically or cytologically confirmed NSCLC or SCLC who have received chemotherapy/radiotherapy at the physician's discretion. And this Cohort aimed to assess the safety of durvalumab for the treatment of lung cancer in clinical practice.
Interventions
DRUGDurvalumab
Patients receive durvalumab as an intravenous infusion over 60 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient capable of proper therapeutic compliance, and accessible to correct follow-up. 2. Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related evaluation and/or intervention. 3. Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority. 4. Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 8). Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC. Brain MRI or high-quality brain CT with intravenous contrast at the time of staging mandatory is strongly recommended. 5. Patients who received definitive concurrent chemoradiation therapy and have not progressed were enrolled in the Cohort 1. Patients who received chemotherapy, radiotherapy or sequential chemotherapy were enrolled in the Cohort 2. 6. Tumour sample requirements: Provision of an unstained tumor samples in a quantity sufficient to allow for analysis (≤3 months newly collected sample is preferred, ≤6 months archival sample is also accepted.) 7. No prior exposure to immune-mediated therapy including, but not limited to, other. 8. anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2. 9. (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Exclusion criteria
1. Patients should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (Cohort 1) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years | PFS is defined as time from the index date (date of the first dose of durvalumab) to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. |
| Overall Survival (Cohort 1) | From baseline until death due to any cause. Assessed up to a maximum of approximately 4 years. | OS is defined as the time from randomization to the time of death from any cause. |
| Number of Participants With one or more Adverse Events (Cohort 2) | Baseline until up to 90 days after end of treatment. | Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from the index date to second progression (Cohort 1) | Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed up to a maximum of approximately 4 years. | PFS2 will be defined as the time from the index date to the earliest of the progression event subsequent to that used for the PFS endpoint or death. |
| Number of Participants With one or more Adverse Events (Cohort 1) | Baseline until up to 90 days after end of treatment. | Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. |
| Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 4 years. | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC Quality of Life Questionnaire and Lung Cancer Module 13 (QLQ-LC13) is a supplemental lung cancer-specific module used in combination with QLQ-C30. An increase in combined score indicates improvement in quality of life. |
| Objective response rate (Cohort 1) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 4 years. | Objective response is defined as best overall response (CR or PR) across all assessment timepoints during the period from enrolment to termination of trial treatment. |
| Overall Survival (Cohort 2) | From baseline until death due to any cause. Assessed up to a maximum of approximately 4 years. | OS is defined as the time from randomization to the time of death from any cause. |
| Objective response rate (Cohort 2) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 4 years. | Objective response is defined as best overall response (CR or PR) across all assessment timepoints during the period from enrolment to termination of trial treatment. |
| Progression-free Survival (Cohort 2) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years. | PFS is defined as time from the index date (date of the first dose of durvalumab) to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. |
| Duration of Response (Cohort 1) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 4 years. | For participants who demonstrated CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. |
| Time to death or distant metastasis (Cohort 1) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 4 years. | TTDM will be defined as the time from the index date (date of the first dose of durvalumab) to the first date of distant metastasis or death in the absence of distant metastasis. |
Countries
China
Contacts
Primary ContactLi Zhang, MD
Outcome results
None listed