NCT06632327|RecruitingPhase 3

Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

CTIU2317-A082304-S2402NCI-2024-06356

Study Type

interventional

Target

1,100

Locations

1 country

Sites

370

Timeline

RegisteredOct 2024

StartedDec 2024

CompletionApr 2030

Brief Summary

This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,100

participants targeted

Target at P75+ for phase_3

Timeline

50mo left

Started Dec 2024

Longer than P75 for phase_3

Geographic Reach

1 country

370 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.4 years study duration

Study Progress25%

Dec 2024Apr 2030

First Submitted

Initial submission to the registry

October 7, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

December 11, 2024

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

October 7, 2024

Last Update Submit

March 2, 2026

Conditions

Resectable Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

3-year real-world event-free survival (rwEFS)
Time to event analyses will be summarized using the Kaplan-Meier method, where both the stratified and unstratified log-rank test will be used to compare the distributions across the treatment arms. For the primary analysis of 3-year rwEFS rate, we will compare the rwEFS curves at 3 years, using the difference in Kaplan-Meier estimates for the survival functions. The test statistic will be derived from the difference in the estimated Kaplan-Meier values between two arms at 3 years, using the Greenwood estimate of the variances. rwEFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. The comparison of the rwEFS post 3-years between the two arms among patients who do not experience an event by 3 years, will involve assessing the probability of a longer rwEFS on the perioperative arm. Non-parametric estimation and inference methods will be used for analysis.
From the date of randomization to the date of the first of the following events: failure to undergo resection for any reason, recurrence or progression at any time after surgery, or death from any cause, assessed at 3 years
Overall survival (OS)
Time to event analyses will be summarized using the Kaplan-Meier method, where both the stratified and unstratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.
From randomization until death from any cause, assessed up to 10 years

Secondary Outcomes (4)

Rates of surgical resection
Up to 10 years.
Rates of complete resection (R0)
Up to 10 years.
Incidence of adverse events (AEs)
Up to 10 years.
Pathological complete response (pCR)
Up to 10 years

Other Outcomes (3)

Estimates of treatment effect by sex
Up to 10 years.
Estimates of treatment effect by race
Up to 10 years
Estimates of treatment effect by ethnicity
Up to 10 years

Study Arms (2)

Arm 1 (surgery, adjuvant therapy)

EXPERIMENTAL

SURGERY: Patients undergo surgery within 28 days of registration. ADJUVANT THERAPY: Patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles and immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines. Patients also undergo CT throughout the study and may undergo MRI and/or PET/CT at screening.

Procedure: Surgical ProcedureDrug: CisplatinDrug: CarboplatinDrug: PemetrexedDrug: GemcitabineDrug: DocetaxelDrug: VinorelbineDrug: NivolumabDrug: PembrolizumabDrug: AtezolizumabProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Arm 2 (neoadjuvant therapy, surgery, adjuvant therapy)

EXPERIMENTAL

NEOADJUVANT THERAPY: Within 28 days of registration, patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles in combination with immune checkpoint inhibitor (nivolumab, pembrolizumab, and/or atezolizumab) according to current approved guidelines. SURGERY: Patients undergo surgery. ADJUVANT THERAPY: Patients receive immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines. Patients also undergo CT throughout the study and may undergo MRI and/or PET/CT at screening.