Conditions: CCND1 Gene Amplification CCND2 Gene Amplification CCND3 Gene Amplification CDK4 Gene Amplification Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief summary:
This phase II/III trial studies how well palbociclib works in treating cell cycle gene alteration positive patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for cell cycle gene alterations which can cause tumor cells to grow more quickly. Palbociclib may slow cell cycle progression and may be able to shrink tumors.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate if there is sufficient evidence to continue to the Phase III component by evaluating the objective response rate (ORR) for cell cycle gene alteration positive patients registered to S1400C treated with palbociclib. (Phase II) II. If the study meets the criteria specified in S1400, the study will be amended to include a follow-on randomized Phase III trial. (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate investigator-assessed progression-free survival (IA-PFS) and overall survival (OS) of cell cycle gene alteration-positive patients treated with palbociclib. (Phase II) II. To evaluate the duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II) III. To evaluate the frequency and severity of toxicities associated with palbociclib. (Phase II)

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To identify additional predictive tumor/blood biomarkers that may modify response or define resistance to palbociclib beyond the chosen biomarker for biomarker-driven sub-studies.

II. To identify potential resistance biomarkers at disease progression. III. To establish a tissue/blood repository from patients with refractory squamous cell carcinoma (SCCA) of the lung.

OUTLINE: As of 09/01/2016, all arms are closed to accrual.

ARM I (CLOSED TO ACCRUAL 09/01/2016): Patients receive palbociclib orally (PO) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Arm III.

ARM III (CLOSED TO ACCRUAL 09/01/2016): Patients in Arm II eligible for re-registration receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, all patients are followed up every 6 months for the first 2 years and then at the end of the year 3 from date of sub-study/re-registration.

Arms:
arm 1: Participants receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Closed to accrual 09/01/2016 arm 2: Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, participants may be eligible to re-register to Arm III.

Closed to accrual 12/18/2015 arm 3: Participants in Arm II eligible for re-registration receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Closed to accrual 09/01/2016

Interventions: intervention 1: Docetaxel intervention 2: Laboratory Biomarker Analysis intervention 3: Palbociclib
Intervention descriptions: intervention 1: Given IV (arm II closed to accrual 12/18/2015) intervention 2: Correlative studies intervention 3: Given PO

Protocol document:
Prot_SAP_000.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400C, “A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration 
Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)” 
 
 
NCT Number: 02785939 
 
 
Version Date: 
9/1/2017 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400C [NCT 02785939].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400C is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


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ICF_001.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400C, “A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration 
Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)” 
 
 
NCT Number: 02785939 
 
 
Version Date: 
9/1/2017 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400C [NCT 02785939].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400C is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


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