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NCT03520842 · ClinicalTrials.gov registry record · Phase 2

Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Stanford University.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT03520842: Completed Phase 2 study, sponsored by Stanford University.

NCT03520842 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03520842, a Phase 2 study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

This phase II trial studies how well regorafenib works together with methotrexate in treating participants with metastatic non-squamous non-small cell lung cancer with tumors that harbor a KRAS mutation. Regorafenib is a targeted therapy that works on different cancer pathways to stop the growth of tumor cells and stop them from spreading. Methotrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving regorafenib and methotrexate together may work in treating participants with KRAS mutated non-small cell lung cancer.

Primary Outcome

Progression free survival (PFS), measured from time of first study treatment until objective tumor progression as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or death from any cause, whichever occurs earlier. PFS was calculated using the Kaplan-Meier method along with 95% confidence interval. RECIST v1.1 criteria are: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diame

Interventions

  • DRUG Regorafenib
  • DRUG Methotrexate
  • OTHER Pharmacokinetic Study

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2018-08-14
Est. Completion 2022-06-15
Phase Phase 2
Stanford University

1,744 total trials

What the finished NCT03520842 record still lists

NCT03520842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which Regorafenib is the first listed.

NCT03520842 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03520842 about?

NCT03520842 is a clinical study titled "Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer". This phase II trial studies how well regorafenib works together with methotrexate in treating participants with metastatic non-squamous non-small cell lung cancer with tumors that harbor a KRAS mutation. Regorafenib is a targeted therapy that works on different cancer pathways to stop the growth of ...

What is the current status of trial NCT03520842?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-08-14. Estimated completion is 2022-06-15.

What interventions are being tested in trial NCT03520842?

The interventions under investigation include: Regorafenib (DRUG), Methotrexate (DRUG), Pharmacokinetic Study (OTHER).

Who is sponsoring clinical trial NCT03520842?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03520842's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03520842, the US trial registry maintained by the National Library of Medicine. NCT03520842 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.