Trial Outcomes & Findings for Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer (NCT NCT01725165)

Last Updated: 2024-10-24

Results Overview

The measurement of overall survival of patients from the start of trial participation until the time their disease progresses or death of the patient. The outcome measures were stratified per the randomization on protocol. The results were not reclassified based on later sequencing. This was all done in accordance to the protocol document.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

16.6 months to 41.2 months for all patients in both LCT and MT/O group

Results posted on

2024-10-24

Participant Flow

Dates of recruitment period: 11/28/2012 to 02/01/2016 ; Location: Multi-center trial that recruited patients at three different hospital sites (MD Anderson Cancer Center, Houston, TX; London Health Sciences Center, London, Ontario; and The University of Colorado, Aurora, CO) 9 patients in the MT/O group received LCT after progression. The remaining 15 did not.

Three patients in the MT/O arm who crossed over to receive LCT before progression were excluded because they did not adhere to either arm of the study.

Participant milestones

Participant milestones
Measure	LCT Arm LCT with radiation therapy or surgery followed by standard maintenance or observation	MT/O Arm Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation
Overall Study STARTED	25	24
Overall Study COMPLETED	14	6
Overall Study NOT COMPLETED	11	18

Reasons for withdrawal

Reasons for withdrawal
Measure	LCT Arm LCT with radiation therapy or surgery followed by standard maintenance or observation	MT/O Arm Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation
Overall Study Death	11	18

Baseline Characteristics

Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LCT Arm n=25 Participants LCT with radiation therapy or surgery followed by standard maintenance or observation	MT/O Arm n=24 Participants Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical >=65 years	11 Participants n=93 Participants	10 Participants n=4 Participants	21 Participants n=27 Participants
Age, Continuous	63 Years n=93 Participants	61 Years n=4 Participants	61 Years n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=93 Participants	24 Participants n=4 Participants	47 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants	18 Participants n=4 Participants	38 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	25 participants n=93 Participants	24 participants n=4 Participants	49 participants n=27 Participants
Patient Characteristics	25 participants n=93 Participants	24 participants n=4 Participants	49 participants n=27 Participants

PRIMARY outcome

Timeframe: 16.6 months to 41.2 months for all patients in both LCT and MT/O group

Outcome measures

Outcome measures
Measure	LCT Arm n=25 Participants LCT with radiation therapy or surgery followed by standard maintenance or observation	MT/O Arm n=24 Participants Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation
Progression-free Survival (PFS)	14.2 Months Interval 7.4 to 23.1	4.4 Months Interval 2.2 to 8.3

SECONDARY outcome

Timeframe: 5.7 to 24.3 months (LCT group); 4.4 to 8.3 months (MT/O group)

The measurement of time to new lesion progression of patients from the start of trial participation until the time their disease progresses. The outcome measures were stratified per the randomization on protocol. The results were not reclassified based on later sequencing. This was all done in accordance to the protocol document.

Outcome measures

Outcome measures
Measure	LCT Arm n=25 Participants LCT with radiation therapy or surgery followed by standard maintenance or observation	MT/O Arm n=24 Participants Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation
Time to New Lesion Progression	14.2 Months Interval 5.7 to 24.3	6 Months Interval 4.4 to 8.3

Adverse Events

LCT Arm

Serious events: 0 serious events

Other events: 14 other events

Deaths: 11 deaths

MT/O Arm

Serious events: 0 serious events

Other events: 12 other events

Deaths: 18 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr, Chad Tang

M D Anderson Cancer Center

Phone: (713) 745-7179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	LCT Arm n=25 participants at risk LCT with radiation therapy or surgery followed by standard maintenance or observation	MT/O Arm n=24 participants at risk Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation
General disorders Fatigue	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Renal and urinary disorders Renal Insufficiency	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Respiratory, thoracic and mediastinal disorders Esophagitis	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Respiratory, thoracic and mediastinal disorders Odynophagia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Skin and subcutaneous tissue disorders Dermatitis	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Gastrointestinal disorders Nausea	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Musculoskeletal and connective tissue disorders Peripheral Sensory Neuropathy	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Nervous system disorders Neuropathy	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Musculoskeletal and connective tissue disorders Peripheral Neuropathy	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Dysphagia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Fever	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Hoarseness	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Pain (of neck)	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Pain (of chestwall)	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Watery eyes	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Back Pain	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Gastrointestinal disorders Constipation	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Respiratory, thoracic and mediastinal disorders Short of Breath	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Gastrointestinal disorders Diverticulitis	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Renal and urinary disorders Chronic Renal Failure	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Blurred Vision	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Pain	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Vascular disorders Thrombophlebitis	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Depression	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Blood and lymphatic system disorders Anion Gap Decrease	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Blood and lymphatic system disorders Neutropenia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Musculoskeletal and connective tissue disorders Left rib pain	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Cellulitis	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Infections and infestations Thrush	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Musculoskeletal and connective tissue disorders Abdominal Pain	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Gastrointestinal disorders Vomiting	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Anorexia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Blood and lymphatic system disorders Edema	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Dry Eyes	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Blood and lymphatic system disorders Hypoxemia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Blood and lymphatic system disorders Hyperkalemia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Skin and subcutaneous tissue disorders Mucositis Oral	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Insomnia	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Headache	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Renal and urinary disorders Urinary difficulties	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Weight loss	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	4.2% 1/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
Skin and subcutaneous tissue disorders Rash	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
General disorders Cough	4.0% 1/25 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.	0.00% 0/24 • From baseline to 61.4 months post treatment. At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.