Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02926638
Status:
TERMINATED
Last Update Posted:
2020-03-19
First Post:
2016-05-06
Brief Title:
Lung-MAP Rilotumumab and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase IIIII Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-Met Positive Patients With Stage IV Squamous Cell Lung Cancer Lung-Map Sub-Study
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug company decided to terminate all sponsored clinical studies involving rilotumumab
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase IIIII compares rilotumumab when given together with erlotinib hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment This is a sub-study that includes all screened patients positive for the met proto-oncogene METhepatocyte growth factor HGF biomarker HGF can interact with MET and can cause tumor cells to grow more quickly Rilotumumab may decrease the activity of HGF and may be able to shrink tumors Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether giving rilotumumab with erlotinib hydrochloride works better than erlotinib hydrochloride alone standard treatment in treating squamous cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival IA-PFS between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E Phase II II To determine if there is both a statistically and clinically-meaningful difference in IA-PFS between patients randomized to receive rilotumumab plus erlotinib versus erlotinib Phase III III To compare overall survival OS in patients randomized to rilotumumab plus erlotinib versus erlotinib Phase III
SECONDARY OBJECTIVES
I To compare response rates confirmed and unconfirmed complete and partial responses among patients randomized to receive rilotumumab plus erlotinib versus erlotinib Phase II II To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib Phase II III To compare the response rates confirmed and unconfirmed complete and partial among patients randomized to receive rilotumumab plus erlotinib versus erlotinib Phase III IV To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib Phase III
TERTIARY OBJECTIVES
I To evaluate the treatment arm randomization acceptance rate within each treatment arm of S1400E defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment
II To identify additional predictive or prognostic tumorblood biomarkers beyond the chosen biomarker
III To identify potential resistance biomarkers at disease progression IV To establish a tissueblood repository from patients with refractory squamous cell cancer
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I CLOSED TO ACCRUAL AND INTERVENTION11252014 Patients receive rilotumumab intravenously IV over 60-120 minutes on day 1 and erlotinib hydrochloride orally PO daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
ARM II CLOSED TO ACCRUAL AND INTERVENTION11252014 Patients receive erlotinib hydrochloride PO daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment all patients will be followed until death or 3 years after sub-study registration whichever occurs first
I To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival IA-PFS between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E Phase II II To determine if there is both a statistically and clinically-meaningful difference in IA-PFS between patients randomized to receive rilotumumab plus erlotinib versus erlotinib Phase III III To compare overall survival OS in patients randomized to rilotumumab plus erlotinib versus erlotinib Phase III
SECONDARY OBJECTIVES
I To compare response rates confirmed and unconfirmed complete and partial responses among patients randomized to receive rilotumumab plus erlotinib versus erlotinib Phase II II To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib Phase II III To compare the response rates confirmed and unconfirmed complete and partial among patients randomized to receive rilotumumab plus erlotinib versus erlotinib Phase III IV To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib Phase III
TERTIARY OBJECTIVES
I To evaluate the treatment arm randomization acceptance rate within each treatment arm of S1400E defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment
II To identify additional predictive or prognostic tumorblood biomarkers beyond the chosen biomarker
III To identify potential resistance biomarkers at disease progression IV To establish a tissueblood repository from patients with refractory squamous cell cancer
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I CLOSED TO ACCRUAL AND INTERVENTION11252014 Patients receive rilotumumab intravenously IV over 60-120 minutes on day 1 and erlotinib hydrochloride orally PO daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
ARM II CLOSED TO ACCRUAL AND INTERVENTION11252014 Patients receive erlotinib hydrochloride PO daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment all patients will be followed until death or 3 years after sub-study registration whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-2014-01382 | REGISTRY | None | None |
| S1400E | None | None | None |
| S1400E | OTHER | None | None |
| S1400E | OTHER | None | None |
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |