Trial Outcomes & Findings for Gene Expression Levels in Predicting Treatment Response in Patients With Stage IV Non-small Cell Lung Cancer (NCT NCT02145078)

Results Overview

A univariable regression of continuous disease response on baseline marker value will be performed. A multivariable regression model adjusted for clinical covariates will be evaluated as well. Expression levels of RRM1, TS, BRCA1, and other molecules and disease response after course 2 will be log-transformed.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline

Results posted on

2020-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy Regimen) Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician. docetaxel: Given IV pemetrexed disodium: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy Regimen) Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician. docetaxel: Given IV pemetrexed disodium: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Overall Study Death	1
Overall Study Reason not given	3

Baseline Characteristics

Gene Expression Levels in Predicting Treatment Response in Patients With Stage IV Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy Regimen) n=4 Participants Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician. docetaxel: Given IV pemetrexed disodium: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: No patient was analyzed.

A univariable regression of continuous disease response on baseline marker value will be performed. A multivariable regression model adjusted for clinical covariates will be evaluated as well. Expression levels of RRM1, TS, BRCA1, and other molecules and disease response after course 2 will be log-transformed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks (after course 2)

Population: No patient was analyzed.

Evaluated using Pearson correlation. If data are not normally distributed after log transformation, a non-parametric method (e.g., Spearman correlation) will be used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of protocol-specified treatment initiation to the date of death or last observation, assessed up to 12 months

Population: All eligible patients.Since, the study was canceled due to slow accrual, no biomarkers were measured; therefore, no analysis with biomarkers. Only the OS will be calculated.

Since, the study was canceled due to slow accrual, no biomarkers were measured; therefore, no analysis with biomarkers. Only the OS will be calculated.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy Regimen) n=4 Participants Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician. docetaxel: Given IV pemetrexed disodium: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival (OS)	2.0 months Interval 1.1 to 7.0

SECONDARY outcome

Timeframe: From the date of protocol-specified treatment initiation to the date of progression, death, or last observation, assessed up to 12 months

Population: No analysis with biomarkers.

Each biomarker evaluated using its expression level (continuous variable) and dichotomous form (based on a median cutoff). A univariable Cox regression model will be used to assess the relationship of expression levels of each biomarker to PFS. In addition, for the dichotomous variables, the sample will be divided into those above and below the median for each biomarker. PFS probabilities for each group will be estimated using the Kaplan-Meier method, with standard errors based on Greenwood's formula. Log rank tests will be used to determine the level of significance between survival curves. Since, the study was canceled due to slow accrual, no biomarkers were measured; therefore, no analysis with biomarkers. Only the PFS will be calculated.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy Regimen) n=4 Participants Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician. docetaxel: Given IV pemetrexed disodium: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Progression-free Survival (PFS)	42 days Interval 34.0 to 60.0

SECONDARY outcome

Timeframe: Up to 8 weeks (end of course 2)

Population: No patient was analyzed.

To assess the relationship between expression levels of RRM1, TS, BRCA1, and other molecules and demographic and disease variables, the Wilcoxon rank sum test or Kruskal-Wallis test for dichotomous or polychotomous categorical variables (such as sex, and histology) and the Spearman correlation coefficient for continuous ordinal variables (such as age or stage) will be used.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Chemotherapy Regimen)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerold Bepler

Barbara Ann Karmanos Cancer Institute

Phone: (313)576-8670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place