Trial Outcomes & Findings for Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN) (NCT NCT01443078)

NCT ID: NCT01443078

Last Updated: 2018-08-09

Results Overview

The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2018-08-09

Participant Flow

Participant milestones

Measure	All Patients Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Overall Study STARTED	42
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Measure	All Patients Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Overall Study Responded to neoadjuvant platinum txt	27
Overall Study Withdrawal by Subject	1
Overall Study Patient had brain mets	1

Baseline Characteristics

Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

Baseline characteristics by cohort

Measure	All Patients n=42 Participants Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline).

Outcome measures

Measure	All Patients n=13 Participants Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
PERCIST Partial Metabolic Response	6 participants

SECONDARY outcome

Timeframe: 2 years

The percentage of patients with a major pathologic response

Outcome measures

Measure	All Patients n=36 Participants Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Pathologic Response Rate	17 percentage of patients Interval 6.0 to 33.0

Adverse Events

All Patients

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients n=42 participants at risk Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Gastrointestinal disorders Anorectal infection	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Metabolism and nutrition disorders Dehydration	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Gastrointestinal disorders Diarrhea	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
General disorders Dyspnea	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
General disorders Febrile neutropenia	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Metabolism and nutrition disorders Hypokalemia	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Cardiac disorders Sinus tachycardia	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Respiratory, thoracic and mediastinal disorders Thromboembolic event	2.4% 1/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.

Other adverse events

Measure	All Patients n=42 participants at risk Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Metabolism and nutrition disorders Hyperglycemia	31.0% 13/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Blood and lymphatic system disorders Neutrophil count decreased	26.2% 11/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Blood and lymphatic system disorders White blood cell decreased	26.2% 11/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Blood and lymphatic system disorders Lymphocyte count decreased	21.4% 9/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
General disorders Fatigue	16.7% 7/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Metabolism and nutrition disorders Hypophosphatemia	16.7% 7/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Metabolism and nutrition disorders Hyponatremia	16.7% 7/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Metabolism and nutrition disorders Anemia	14.3% 6/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Cardiac disorders Hypertension	7.1% 3/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 3/42 There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.

Additional Information

Chaft, Jamie, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4545

Email: ChaftJ@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place