Trial · NCT04292119
Lorlatinib Combinations in Lung Cancer
NCT04292119, Phase 1, Phase 2, Unknown, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lorlatinib Combinations in Lung Cancer. Trials, record NCT04292119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04292119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lorlatinib Combinations in Lung Cancer
- NCT number
- NCT04292119
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 96 participants, estimated
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Lung Cancer, Anaplastic Lymphoma Kinase Gene Translocation, ROS1 Rearrangement, Relapsed Cancer, MET Amplification, Resistant Cancer, NSCLC
- Interventions
- Lorlatinib, Crizotinib, Binimetinib, TNO155
- First posted
- 2020-03-02
- Last updated
- 2021-03-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose as assessed by CTCAE v5.0. Phase I. | 28 days (binimetinib and crizotinib arm), 21 days (TNO155 arm) | The highest dose of the combinations that does not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses in different groups of patients until the highest dose with acceptable side effects is found. |
| Primary | The objective response rate, including partial and complete responses, as evaluated by RECIST v1.1. Phase II | 24 months | Objective response rate (partial and complete responses) will be evaluated according to RECIST v1.1 criteria. |
| Secondary | Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE V5.0 | From first dose to end of study. Time frame is anticipated to be 24 months. | Number of patients with treatment-related side effects, according to CTCAE v5.0 |
| Secondary | Progression-Free Survival as assessed by RECIST v1.1 and the Kaplan-Meier Method | Time from the start of study drug treatment to the date of the first documented progression or death due to disease, likely average of 12 months | PFS will defined as the time from the start of treatment to the date of the first documented progression or death due to disease. The distribution of PFS will be estimated using the Kaplan-Meier method. |
| Secondary | Duration of Response to Treatment as Assessed by RECIST v1.1 | Measured from the time measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documented or the date of death due to any cause, likely average of 12 months | Duration of response to treatment is measured from the time that measurement criteria (RECIST v1.1) are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), or death due to any cause. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04292119
GET https://conductscience.org/api/trials/v1/NCT04292119/registered