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New treatment option for Previously Treated Non-Small Cell Lung Cancer
Official title Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT03851445
What this study is testing
What is Screening Platform?
Screening Platform is an investigational medicine, being studied as a potential treatment for previously treated non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 5.1 Registration Step 0:
- Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to...
- Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration...
- Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment...
- Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least one line of systemic...
See the full eligibility criteria
- 5.1 Registration Step 0:
- Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to obtain a patient ID number for the submission. Patients registered to...
- Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent. The...
- Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment. These criteria are:
- Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed...
- For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have...
- For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g...
- Pre-Screening prior to progression on current treatment: To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current...
- Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.
- The local interpreting pathologist must review the specimen.
- The pathologist must sign the LUNGMAP Local Pathology Review Form confirming tissue adequacy prior to Step 1 registration. Patients must agree to have this tissue submitted to Foundation Medicine for common broad...
- Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all standard of care targeted...
- Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration.
- Patients must be ≥ 18 years of age.
- Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
- Patients must be willing to provide prior smoking history as required on the LUNGMAP Onstudy Form.
- As a part of the OPEN registration process (see Section 13.4 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional...
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study if local institution's policies allow participants to...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Goodyear, Arizona, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Antioch, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Berkeley, California, United States
+ 790 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Daphne, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Anchorage, Alaska, United States and 804 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.