Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy

June 2, 2026 updated by: National Cancer Institute (NCI)

A Randomized Phase II Trial of Sacituzumab Govitecan (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving sacituzumab govitecan and bevacizumab may kill more tumor cells than standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with recurrent platinum-sensitive ovarian cancers that have BRCA1/2 mutations or homologous recombination deficiency.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the clinical activity of sacituzumab govitecan (sacituzumab govitecan-hziy [SG]) and bevacizumab (or an anti-VEGF antibody biosimilar) compared to standard of care carboplatin, pegylated liposomal doxorubicin hydrochloride (pegylated liposomal doxorubicin [PLD]) and bevacizumab (or an anti-VEGF antibody biosimilar), as measured by progression-free survival, in patients with platinum-sensitive ovarian cancer that has progressed while receiving first-line PARP inhibitor maintenance therapy.

SECONDARY OBJECTIVES:

I. To assess additional measures of clinical activity, including overall response rate and duration of response, of SG and bevacizumab compared to standard of care carboplatin, PLD and bevacizumab in patients with recurrent platinum-sensitive ovarian cancer.

II. To assess the safety of SG and bevacizumab in patients with recurrent platinum-sensitive ovarian cancer.

EXPLORATORY OBJECTIVES:

I. To correlate clinical activity of SG and bevacizumab with TROP2 expression and tumor-specific cell-free deoxyribonucleic acid (cfDNA).

II. To assess time to first subsequent therapy or death (TFST). III. To assess time to second subsequent therapy or death (TSST).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive carboplatin intravenously (IV) on day 1, PLD IV on day 1 (or gemcitabine IV on days 1 and 8), and bevacizumab (or anti-VEGF antibody biosimilar) IV on days 1 and 15 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy.

ARM II: Patients receive SG IV on days 1 and 8 and bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy.

MAINTENANCE: Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients in Arm I also undergo echocardiography (ECHO) at screening and all patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologic diagnosis of high grade serious or endometrioid epithelial ovarian cancer

    • Ovarian cancer = fallopian tube, ovarian, and primary peritoneal cancer
  • Disease must be platinum sensitive, as defined by progression documented ≥ 6 months (182 days) from the last receipt of platinum
  • Disease must have progressed during first line maintenance PARP inhibitor (PARPi) for advanced ovarian cancer. NO intervening therapies between progression on PARPi and study registration are permitted
  • Disease must be germline or somatic BRCA1 or BRCA2 mutated or homologous recombination deficiency test positive
  • Disease must be measurable or assessable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1
  • Patients with treated brain metastases are eligible if follow up brain imaging 4 weeks after central nervous system (CNS) directed therapy shows no evidence of progression
  • Secondary or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted
  • No previous receipt of any topoisomerase-I inhibiting agents
  • No investigational agents within 4 weeks of study registration
  • No current treatment with any other (non-study) cytotoxic chemotherapy, targeted therapy, biologic therapy, immunotherapy or endocrine therapy for the treatment of the disease under the current study
  • Last dose of PARP inhibitor treatment must be ≥ 3 weeks before study registration
  • Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Not pregnant and not nursing
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 9 g/dl is acceptable)
  • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  • Urinalysis with ≤ 1+ protein and/or urine protein < 1.0 g/24 hours (hrs)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better
  • No active infection requiring parenteral antibiotics
  • No non-healing wound, ulcer, or bone fracture
  • No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
  • No clinically significant bleeding within 28 days prior to registration
  • No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg

  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the following exceptions:

    • Participants with grade 2 or lower neuropathy, any grade alopecia, well controlled hypertension, thyroid disease controlled with therapy, and history of thromboembolic disease on anticoagulation are eligible
    • Participants with laboratory-based grade 2 or higher adverse events (AEs) that meet the criteria outlined above are eligible
  • No major surgery within 3 weeks prior to study entry
  • Patients who underwent major surgery must have recovered adequately from any toxicity and/or complications from surgery prior to starting therapy
  • No strong inhibitors or inducers of UGT1A1
  • No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (carboplatin, PLD, bevacizumab)

Patients receive carboplatin IV on day 1, PLD IV on day 1 (or gemcitabine IV on days 1 and 8), and bevacizumab (or anti-VEGF antibody biosimilar) IV on days 1 and 15 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy.

MAINTENANCE: Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo ECHO at screening and undergo CT and/or MRI and collection of blood samples throughout the trial.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Other Names:
  • ATI-0918
  • Caelyx
  • Doxil
  • Doxilen
  • Doxorubicin HCl Liposome
  • Duomeisu
  • Evacet
  • LipoDox
  • Liposomal Adriamycin
  • Liposomal-Encapsulated Doxorubicin
  • Pegylated Doxorubicin HCl Liposome
  • S-Liposomal Doxorubicin
  • Stealth Liposomal Doxorubicin
  • TLC D-99
  • Dox-SL
  • Doxorubicin HCl Liposomal
  • Doxorubicin Hydrochloride Liposome
  • Lipodox 50
  • Liposomal Doxorubicin Hydrochloride
  • Pegylated Liposomal Doxorubicin
  • Doxorubicin Liposomal
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Gemcitabine
Given IV
Other Names:
  • dFdCyd
  • dFdC
  • Difluorodeoxycytidine
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody SIBP04
  • Anti-VEGF rhuMAb
  • Bevacizumab awwb
  • Bevacizumab Biosimilar ABP 215
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar GB-222
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar Mvasi
  • Bevacizumab Biosimilar MYL-1402O
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • Bevacizumab Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma
  • Alymsys
  • ABP-215
  • ABP215
  • Aybintio
  • Bevacizumab-aybi
  • Bevacizumab-equi
  • Bevacizumab-maly
  • Bevacizumab-onbe
  • CT P16
  • CTP16
  • Equidacent
  • Onbevzi
  • Avzivi
  • Bevacizumab Biosimilar MB02
  • Bevacizumab-tnjn
  • FKB 238
  • FKB-238
  • FKB238
  • MB 02
  • MB-02
  • MB02
  • Oyavas
  • PF 06439535
  • PF-06439535
  • PF06439535
  • Bevacizumab-aveg
  • Bevacizumab-byva
  • Bevacizumab-nwgd
  • Jobevne
Procedure: Echocardiography Test
Undergo ECHO
Other Names:
  • Echocardiography
  • EC
Biological: Anti-VEGF Monoclonal Antibody
Given IV
Other Names:
  • MoAb VEGF
  • Monoclonal Antibody Anti-VEGF
Experimental: Arm II (SG, bevacizumab)

Patients receive SG IV on days 1 and 8 and bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy.

MAINTENANCE: Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody SIBP04
  • Anti-VEGF rhuMAb
  • Bevacizumab awwb
  • Bevacizumab Biosimilar ABP 215
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar GB-222
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar Mvasi
  • Bevacizumab Biosimilar MYL-1402O
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • Bevacizumab Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma
  • Alymsys
  • ABP-215
  • ABP215
  • Aybintio
  • Bevacizumab-aybi
  • Bevacizumab-equi
  • Bevacizumab-maly
  • Bevacizumab-onbe
  • CT P16
  • CTP16
  • Equidacent
  • Onbevzi
  • Avzivi
  • Bevacizumab Biosimilar MB02
  • Bevacizumab-tnjn
  • FKB 238
  • FKB-238
  • FKB238
  • MB 02
  • MB-02
  • MB02
  • Oyavas
  • PF 06439535
  • PF-06439535
  • PF06439535
  • Bevacizumab-aveg
  • Bevacizumab-byva
  • Bevacizumab-nwgd
  • Jobevne
Biological: Sacituzumab Govitecan
Given IV
Other Names:
  • IMMU-132
  • Trodelvy
  • Sacituzumab Govitecan-hziy
  • hRS7-SN38 Antibody Drug Conjugate
  • RS7-SN38
  • IMMU 132
  • IMMU132
  • RS7 SN38
  • RS7SN38
Biological: Anti-VEGF Monoclonal Antibody
Given IV
Other Names:
  • MoAb VEGF
  • Monoclonal Antibody Anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From randomization to either progressive disease or death from any cause, assessed up to 5 years
The primary analysis will compare progression-free survival between Arm II and Arm I using a stratified log-rank test. The corresponding hazard ratio will be estimated from a stratified Cox regression model. The treatment hazard ratio estimate and its 95% confidence interval will be estimated using proportional hazards models specified to be consistent with the logrank tests.
From randomization to either progressive disease or death from any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 5 years
The nature, frequency, and degree of toxicity will be tabulated at the System Organ Class and adverse event-specific term levels using Common Terminology Criteria for Adverse Events version 5.0. Each patient will be represented according to the maximum grade observed for each term. Tabulations will show the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment.
Up to 5 years
Objective response rate (ORR)
Time Frame: Within 12 months of starting maintenance therapy
The ORR is the percentage of evaluable patients who achieve a complete response (CR) or partial response (PR) within 12 months of starting maintenance therapy. The analysis will be based on physician-assessed responses according to Response Evaluation Criteria in Solid Tumors 1.1 criteria. Comparisons of ORR between the experimental and reference groups will use a multivariable logistic regression model, stratified by the randomization factors, to estimate the odds ratio. A 95% Jeffries confidence interval will also be calculated for the ORR in each treatment arm.
Within 12 months of starting maintenance therapy
Duration of response (DOR)
Time Frame: From the first documented response (CR or PR) until disease progression or death, assessed up to 5 years
DOR will be visualized using Kaplan-Meier curves, and the treatment groups will be compared with a stratified log-rank test. A stratified Cox proportional hazards model will be used to estimate the hazard ratio for progression or death between the groups.
From the first documented response (CR or PR) until disease progression or death, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TROP2 expression
Time Frame: Up to 5 years
TROP2 expression will be correlated with clinical activity of sacituzumab govitecan (SG) and bevacizumab to assess how the clinical effect of the randomized treatment is modified by TROP2 expression. Will formally test the interaction between the biomarker and the treatment assignment to assess whether this is a predictive biomarker. A logistic regression model will be used to test the treatment-by-TROP2 interaction on the odds of achieving a response. The odds ratio for the treatment effect will be estimated within each TROP2 subgroup. A Cox proportional hazards model will be fitted with main effects for treatment, TROP2 status, and a treatment-by-TROP2 interaction term. A statistically significant interaction term would suggest TROP2 is a predictive biomarker. The treatment effect will be estimated and displayed on a forest plot for TROP2-high and TROP2-low subgroups. Kaplan-Meier curves for PFS will be plotted for each treatment arm within each TROP2 subgroup.
Up to 5 years
Cell-free deoxyribonucleic acid (cfDNA)
Time Frame: Up to 5 years
cfDNA expression will be correlated with clinical activity of SG and bevacizumab to assess how the clinical effect of the randomized treatment is modified by cfDNA expression. Will formally test the interaction between the biomarker and the treatment assignment to assess whether this is a predictive biomarker.
Up to 5 years
Time to first subsequent therapy or death (TFST)
Time Frame: From randomization to the earliest occurrence of either first subsequent therapy or death, assessed up to 5 years
TFST distributions by randomized treatment assignment in the intent to treat population will be visualized using Kaplan-Meier curves. The effect of treatment assignment on TFST will be estimated using a Cox proportional hazards model, stratified by the randomization factors. Hazard ratio estimates and 95% confidence intervals will be reported to quantify the treatment effect. Treatment effects within strata will be presented in a forest plot.
From randomization to the earliest occurrence of either first subsequent therapy or death, assessed up to 5 years
Time to second subsequent therapy or death (TSST)
Time Frame: From randomization to the earliest occurrence of either second subsequent therapy or death, assessed up to 5 years
TSST distributions by randomized treatment assignment in the intent to treat population will be visualized using Kaplan-Meier curves. The effect of treatment assignment on TSST will be estimated using a Cox proportional hazards model, stratified by the randomization factors. Hazard ratio estimates and 95% confidence intervals will be reported to quantify the treatment effect. Treatment effects within strata will be presented in a forest plot.
From randomization to the earliest occurrence of either second subsequent therapy or death, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Rebecca L Porter, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

April 12, 2029

Study Completion (Estimated)

April 12, 2029

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2026-01998 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NRG-GY038 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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