Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-10
Brief Title:
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer INSIGHT Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting INSIGHT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares durvalumab to the usual approach patient observation after surgery for the treatment of patients with early-stage non-small cell lung cancer Immunotherapy with monoclonal antibodies such as durvalumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread The usual approach for patients who are not in a study is to closely watch a patients condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back Usually patients do not receive further treatment unless the cancer returns This study will help determine whether this different approach with durvalumab is better the same or worse than the usual approach of observation Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach
Detailed Description:
PRIMARY OBJECTIVE
I To compare disease free survival DFS in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response pCR following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab MEDI4736 versus surveillance
SECONDARY OBJECTIVES
I To compare the overall survival OS between the arms II To evaluate the frequency and severity of toxicities of adjuvant durvalumab MEDI4736
III To compare the event free survival EFS between the arms
TRANSLATIONAL MEDICINE OBJECTIVE
I To bank specimens and images for additional future translational medicine studies
QUALITY OF LIFE QOL PRIMARY OBJECTIVE
I To compare patient-reported quality of life QOL status between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Lung FACT-L Trial Outcome Index TOI
QOL SECONDARY OBJECTIVES
I To compare patient-reported quality of life between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Biologic Response Modifier FACT-BRM physical and mental subscale scores
II To compare longitudinal changes in global health status between treatment arms from randomization to 12 months using the FACT-L TOI
PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS PRO-CTCAE OBJECTIVE
I To compare participant-reported symptoms using selected PRO-CTCAE items between treatment arms such as rash itching skin dryness numbness and tingling
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive durvalumab intravenously IV over 60 minutes on day 1 of each cycle Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT and blood sample collection throughout the trial
ARM II Patients undergo active surveillance for 12 months on study Patients undergo CT and blood sample collection throughout the trial
After completion of study treatment patients are followed up annually until 10 years from randomization
I To compare disease free survival DFS in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response pCR following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab MEDI4736 versus surveillance
SECONDARY OBJECTIVES
I To compare the overall survival OS between the arms II To evaluate the frequency and severity of toxicities of adjuvant durvalumab MEDI4736
III To compare the event free survival EFS between the arms
TRANSLATIONAL MEDICINE OBJECTIVE
I To bank specimens and images for additional future translational medicine studies
QUALITY OF LIFE QOL PRIMARY OBJECTIVE
I To compare patient-reported quality of life QOL status between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Lung FACT-L Trial Outcome Index TOI
QOL SECONDARY OBJECTIVES
I To compare patient-reported quality of life between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Biologic Response Modifier FACT-BRM physical and mental subscale scores
II To compare longitudinal changes in global health status between treatment arms from randomization to 12 months using the FACT-L TOI
PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS PRO-CTCAE OBJECTIVE
I To compare participant-reported symptoms using selected PRO-CTCAE items between treatment arms such as rash itching skin dryness numbness and tingling
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive durvalumab intravenously IV over 60 minutes on day 1 of each cycle Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT and blood sample collection throughout the trial
ARM II Patients undergo active surveillance for 12 months on study Patients undergo CT and blood sample collection throughout the trial
After completion of study treatment patients are followed up annually until 10 years from randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-05588 | REGISTRY | None | None |
| S2414 | OTHER | None | None |
| S2414 | OTHER | None | None |
| U10CA180888 | NIH | None | None |