Trial · NCT03520842
Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer
NCT03520842, Phase 2, Completed, Stanford University; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer. Trials, record NCT03520842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03520842
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer
- NCT number
- NCT03520842
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- KRAS Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7
- Interventions
- Methotrexate, Pharmacokinetic Study, Regorafenib
- First posted
- 2018-05-11
- Last updated
- 2023-08-01
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From first study treatment assessed up to 15 months | 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 diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria |
| Secondary | Objective Response Rate (ORR) | Up to 24 months | Objective response rate (ORR; as determined by RECIST v1.1) will be assessed as the proportion (percent) of participants with either complete response (CR; disappearance of all target lesions) or partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), with exact 95% confidence intervals based on a binomial distribution. |
| Secondary | Disease Control Rate (DCR) | At 8 weeks | Disease control rate (DCR) will be assessed as the proportion of complete responses (CR) + partial responses (PR) + stable disease (SD) after 8 weeks of treatment (+/- 1 week), as determined by using RECIST v1.1 |
| Secondary | Number of Participants With Adverse Events | Up to 38 months | Participants who experienced any treatment emergent adverse event and any ≥ grade 3 adverse event is reported. |
| Secondary | Trough Serum Concentration of Methotrexate | Cycle 1, Days 1, 8, 15, and 22 | Pharmacokinetics (PK) of methotrexate when co-administered with regorafenib, as indicated by the trough serum concentration, was accessed by a fluorescent polarization immunoassay, and is reported as the mean with standard deviation. Participants treated with at least 1 dose of regorafenib and methotrexate and with at least one evaluable baseline pharmacokinetic sample and one follow up trough pharmacokinetic sample treated were included. |
| Secondary | Maximum Serum Concentration (Cmax) of Methotrexate | Cycle 1, Days 1, 8, and 15 | Pharmacokinetics (PK) of methotrexate when co-administered with regorafenib, as indicated by the maximum serum concentration (Cmax) of methotrexate, was assessed by a fluorescent polarization immunoassay, and is reported as the mean with standard deviation. Participants treated with at least 1 dose of regorafenib and methotrexate and with at least one evaluable Cmax pharmacokinetic sample were included in the assessment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From first study treatment assessed up to 15 months | months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | Up to 24 months | percentage of participants | MEDIAN | |
| SECONDARY | Disease Control Rate (DCR) | At 8 weeks | percentage of participants | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | Up to 38 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Trough Serum Concentration of Methotrexate | Cycle 1, Days 1, 8, 15, and 22 | μmol/L | MEAN | |
| SECONDARY | Maximum Serum Concentration (Cmax) of Methotrexate | Cycle 1, Days 1, 8, and 15 | μmol/L | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Treatment (Regorafenib, Methotrexate) | 3.7 | 95% Confidence Interval 1.8 to 8.6 | months | |
| Objective Response Rate (ORR) | Treatment (Regorafenib, Methotrexate) | 16.7 | 95% Confidence Interval 3.5 to 41.4 | percentage of participants | |
| Disease Control Rate (DCR) | Treatment (Regorafenib, Methotrexate) | 66.7 | 95% Confidence Interval 41.0 to 86.7 | percentage of participants | |
| Number of Participants With Adverse Events | Treatment (Regorafenib, Methotrexate) | Any grade | 17 | Participants | |
| Number of Participants With Adverse Events | Treatment (Regorafenib, Methotrexate) | ≥ grade 3 | 14 | Participants | |
| Trough Serum Concentration of Methotrexate | Treatment (Regorafenib, Methotrexate) | Cycle 1, Day 1 | 0.04 | Standard Deviation 0.02 | μmol/L |
| Trough Serum Concentration of Methotrexate | Treatment (Regorafenib, Methotrexate) | Cycle 1, Day 8 | 0.04 | Standard Deviation 0.01 | μmol/L |
| Trough Serum Concentration of Methotrexate | Treatment (Regorafenib, Methotrexate) | Cycle 1, Day 15 | 0.05 | Standard Deviation 0.03 | μmol/L |
| Trough Serum Concentration of Methotrexate | Treatment (Regorafenib, Methotrexate) | Cycle 1, Day 22 | 0.05 | Standard Deviation 0.02 | μmol/L |
| Maximum Serum Concentration (Cmax) of Methotrexate | Treatment (Regorafenib, Methotrexate) | Cycle 1, Day 1 | 0.43 | Standard Deviation 0.23 | μmol/L |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Regorafenib, Methotrexate) | 18 | |
| Overall Study | COMPLETED | Treatment (Regorafenib, Methotrexate) | 18 | |
| Overall Study | NOT COMPLETED | Treatment (Regorafenib, Methotrexate) | 0 |
Source ClinicalTrials.gov
Adverse events133
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Regorafenib, Methotrexate) | 1 | 18 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Regorafenib, Methotrexate) | 3 | 18 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Regorafenib, Methotrexate) | 4 | 18 | |
| other | Amylase increased | Investigations | Treatment (Regorafenib, Methotrexate) | 3 | 18 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Regorafenib, Methotrexate) | 8 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Regorafenib, Methotrexate) | 1 | 18 | |
| other | Anxiety | Psychiatric disorders | Treatment (Regorafenib, Methotrexate) | 1 | 18 | |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Regorafenib, Methotrexate) | 3 | 18 | |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | Treatment (Regorafenib, Methotrexate) | 1 | 18 | |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Regorafenib, Methotrexate) | 1 | 18 |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Regorafenib, Methotrexate) | 2 | 18 |
| Total, other adverse events | Treatment (Regorafenib, Methotrexate) | 17 | 18 |
| Total, serious adverse events | Treatment (Regorafenib, Methotrexate) | 8 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03520842
GET https://conductscience.org/api/trials/v1/NCT03520842/events?page=2