Trial · NCT01306045
Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies
NCT01306045, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies. Trials, record NCT01306045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01306045
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies
- NCT number
- NCT01306045
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 647 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell Lung, Carcinoma, Thymic
- Interventions
- AZD6244, MK-2206, Lapatinib, Erlotinib, Sunitinib, Molecular Profiling
- First posted
- 2011-03-01
- Last updated
- 2024-10-01
- Results first posted
- 2023-04-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | 1 year and 11 months | To determine the feasibility of the use of tumor molecular profiling and targeted therapies in the treatment of Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies, the trial will be evaluated by determining the percentage of enrolled participants with a genomic abnormality. Identifying molecular profiles may help identify new targeted treatments for cancer. |
| Primary | Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies | 1 year and 13 months | Efficacy will be determined by assessing if participants who have treatment assigned on the basis of their molecular profiling results will exhibit reasonable response to the drug selected for their particular profile. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study Progressive Disease (PD) is At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions. |
| Primary | Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile | 1 year and 13 months | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).Partial Response (PD) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study Progressive Disease (PD) is At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions. |
| Other | Frequency of Epidermal Growth Factor Receptor (EGFR) Germline Mutations in Families With High Susceptibility to Lung Cancer | 5 years | The frequency of EGFR germline mutations will be determined by enrolling participants from families with high susceptibility to lung cancer and their first-degree relatives (at the National Cancer Institute (NCI) site only). Individuals were tested for Epidermal Growth Factor Receptor (EGFR) Germline Mutations if they consented to participation in the study and had a personal history of invasive NSCLC or one of the pre-invasive histologies associated with the development of non-small cell lung cancer (NSCLC) and more than two affected family members with invasive NSCLC or one of the pre-invasive histologies associated with the development of NSCLC; OR a first-degree relative with a known EGFR germline mutation (EGFR threonine (T) with methionine (M) at position 790 of exon 20 (T790M), exon 21 V843I, exon 21 R831C and exon 20 R776G). |
| Other | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 122 months and 25 days, 88 months and 16 days, and 126 months and 2 days for each group respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | 1 year and 11 months | For tolerability, data has been separated by type of malignancy since the information being conveyed represents overall tolerability in participants with a given malignancy. | percentage of participants | NUMBER |
| PRIMARY | Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies | 1 year and 13 months | Overall number of participants analyzed represent the total number of participants for each tumor type evaluable for response (efficacy) across different treatment arms. For tolerability, data has been separated by type of malignancy since the information being conveyed represents overall tolerability in participants with a given malignancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile | 1 year and 13 months | Overall number of participants analyzed represent the total number of participants for each tumor type evaluable for response (efficacy) across different treatment arms. For tolerability, data has been separated by type of malignancy since the information being conveyed represents overall tolerability in participants with a given malignancy. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Frequency of Epidermal Growth Factor Receptor (EGFR) Germline Mutations in Families With High Susceptibility to Lung Cancer | 5 years | As pre-specified in the protocol, only the NSCLC group is reported here. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 122 months and 25 days, 88 months and 16 days, and 126 months and 2 days for each group respectively. | Serious and/or Non-Serious adverse events data was collected for 423/647 participants because the remainder did not undergo any study-related intervention because a new biopsy was not performed (archival tissue was used for molecular profiling) and/or the participant failed to enroll in one of the treatment arms. For tolerability, data has been separated by type of malignancy since the information being conveyed represents overall tolerability in participants with a given malignancy. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group109
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Non-Small Cell Lung Cancer (NSCLC) | Tumor protein p53 (TP53) | 28.5 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Small Cell Lung Cancer (SCLC) | Tumor protein p53 (TP53) | 44.2 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Thymic Malignancies | Tumor protein p53 (TP53) | 0 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Non-Small Cell Lung Cancer (NSCLC) | Kirsten rat sarcoma virus (KRAS) | 24.9 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Small Cell Lung Cancer (SCLC) | Kirsten rat sarcoma virus (KRAS) | 4.1 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Thymic Malignancies | Kirsten rat sarcoma virus (KRAS) | 0 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Non-Small Cell Lung Cancer (NSCLC) | Epidermal growth factor receptor (EGFR) | 22.1 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Small Cell Lung Cancer (SCLC) | Epidermal growth factor receptor (EGFR) | 2.0 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Thymic Malignancies | Epidermal growth factor receptor (EGFR) | 1 | percentage of participants | |
| Percentage of Enrolled Participants Testing Positive for Genomic Abnormality | Non-Small Cell Lung Cancer (NSCLC) | PDGFRA amplifications | 12.8 | percentage of participants |
1 to 10 of 109Source ClinicalTrials.gov
See all 109 results by groupParticipant flow51
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Met General Eligibility Criteria | STARTED | Participants With Non-Small Cell Lung Cancer | 481 | |
| Met General Eligibility Criteria | STARTED | Participants With Small Cell Lung Cancer | 68 | |
| Met General Eligibility Criteria | STARTED | Participants With Thymic Malignancies | 98 | |
| Met General Eligibility Criteria | Had EGFR Mutations | Participants With Non-Small Cell Lung Cancer | 88 | |
| Met General Eligibility Criteria | Had EGFR Mutations | Participants With Small Cell Lung Cancer | 1 | |
| Met General Eligibility Criteria | Had EGFR Mutations | Participants With Thymic Malignancies | 1 | |
| Met General Eligibility Criteria | Had KRAS, HRAS, NRAS, or BRAF Mutations | Participants With Non-Small Cell Lung Cancer | 103 | |
| Met General Eligibility Criteria | Had KRAS, HRAS, NRAS, or BRAF Mutations | Participants With Small Cell Lung Cancer | 5 | |
| Met General Eligibility Criteria | Had KRAS, HRAS, NRAS, or BRAF Mutations | Participants With Thymic Malignancies | 2 | |
| Met General Eligibility Criteria | Had PTEN, Akt1, or PIK3CA Abnormalities | Participants With Non-Small Cell Lung Cancer | 22 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 participant flowAdverse events408
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 | Non-Small Cell Lung Cancer (NSCLC) | 1 | 310 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Small Cell Lung Cancer (SCLC) | 0 | 22 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Thymic Malignancies | 0 | 0 | 0 |
| other | Alanine aminotransferase increased | Investigations | Non-Small Cell Lung Cancer (NSCLC) | 7 | 310 | 8 |
| other | Alanine aminotransferase increased | Investigations | Small Cell Lung Cancer (SCLC) | 0 | 22 | 0 |
| other | Alanine aminotransferase increased | Investigations | Thymic Malignancies | 0 | 0 | 0 |
| other | Alkaline phosphatase increased | Investigations | Non-Small Cell Lung Cancer (NSCLC) | 6 | 310 | 10 |
| other | Alkaline phosphatase increased | Investigations | Small Cell Lung Cancer (SCLC) | 0 | 22 | 0 |
| other | Alkaline phosphatase increased | Investigations | Thymic Malignancies | 0 | 0 | 0 |
| other | Allergic reaction | Immune system disorders | Non-Small Cell Lung Cancer (NSCLC) | 2 | 310 | 2 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-Small Cell Lung Cancer (NSCLC) | 467 | 481 |
| Total, all-cause mortality | Small Cell Lung Cancer (SCLC) | 68 | 68 |
| Total, all-cause mortality | Thymic Malignancies | 88 | 98 |
| Total, other adverse events | Non-Small Cell Lung Cancer (NSCLC) | 37 | 310 |
| Total, other adverse events | Small Cell Lung Cancer (SCLC) | 1 | 22 |
| Total, other adverse events | Thymic Malignancies | 3 | 91 |
| Total, serious adverse events | Non-Small Cell Lung Cancer (NSCLC) | 15 | 310 |
| Total, serious adverse events | Small Cell Lung Cancer (SCLC) | 0 | 22 |
| Total, serious adverse events | Thymic Malignancies | 3 | 91 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT01306045
GET https://conductscience.org/api/trials/v1/NCT01306045/results?page=2