Erlotinib Hydrochloride in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

back

Erlotinib Hydrochloride in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

Status

Closed

Cancer Type

Lung Cancer

Trial Phase

Phase III

Eligibility

18 Years and older, Male and Female

Study Type

Treatment

NCT ID

NCT02193282

Protocol IDs

NCI-2014-01508 (primary)
U10CA031946
U10CA180821
A081105

Study Sponsor

Alliance for Clinical Trials in Oncology

NCI Full Details

http://clinicaltrials.gov/show/NCT02193282

Summary

This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery (resected). Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVE:
I. To assess whether adjuvant therapy with erlotinib hydrochloride (erlotinib) will result in improved overall survival (OS) over observation for patients with completely resected stage IB (>= 4 cm)-IIIA epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) (confirmed centrally) following complete resection and standard post-operative therapy.

SECONDARY OBJECTIVES:
I. To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over observation for patients with completely resected stage IB (>= 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
II. To evaluate the safety profile of erlotinib in the adjuvant setting.
III. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 and 10 years over observation for patients with completely resected stage IB (>= 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
IV. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.
V. To study detection of circulating EGFR mutations in cell-free plasma deoxyribonucleic acid (DNA) as a prognostic marker in resected early stage NSCLC.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM A (BLINDED ERLOTINIB- CLOSED 06/14/17): Blinded patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B (PLACEBO- CLOSED 06/14/17): Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM C (UNBLINDED ERLOTINIB): Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM D (OBSERVATION): Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.

After completion of study treatment, patients are followed up every 6 months for 4 years and then yearly for 6 years.

Eligibility

Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria: a) Patient registered to A151216 and the assessment performed centrally by the protocol-specified laboratory b) By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results * Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible * Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105
Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration
Non-pregnant and non-lactating
No history of cornea abnormalities
Granulocytes >= 1,500/ul
Platelets >= 100,000/ul
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Ronald G. Steis MD

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Doctors:

Richard A. Carter MD

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com

Doctors:

Sreekanth C. Reddy MD
Ronald G. Steis MD
Amelia B. Zelnak MD
Kelly A. May MD

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Kelly A. May MD

Cancer Center at DeKalb Medical Center

2675 North Decatur Road
Suite 410
Decatur, GA 30033
404-501-7789
www.dekalbmedical.org

Doctors:

Jayanthi Srinivasiah MD

Emory Saint Joseph's Hospital

5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Doctors:

Ranjana S. Bhargava MD
Priya Rudolph

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD
Simbo O. Aduloju MD
Aaron R. Alizadeh MD
Kathleen E. Lambert MD

Gwinnett Medical Center

1000 Medical Center Boulevard
Lawrenceville, GA 30046
404-851-2340
www.gwinnettmedicalcenter.org

Study Coordinator:
Qun Zeng
678-312-3828

Doctors:

Allan Freedman MD
Christopher T. Hagenstad MD
Aldemar Montero MD
Alexander F. Saker, Jr. MD
P. Ravi Sarma MD, FACP
Philip D. Shrake MD
Satvir Singh MD
Kevin H. Peacock MD
Mohan Krishnamachary MD

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler

225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

Doctors:

John A. Pablo MD
Mark A. Taylor MD
Grant C. Lewis MD
Ronald Goldberg MD
Alison Spellman MD
Gary W. Thomas MD
Majd Chahin MD

Northeast Georgia Medical Center - Gainesville

NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

Study Coordinator:
Trena Davis BSN, RN, CRCC
770-219-8822

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:
404-303-3355

Doctors:

Pradeep C. Jolly MD
Cheryl F. Jones MD
Jayanthi Srinivasiah MD
Gena H. Volas-Redd MD
Amelia B. Zelnak MD
Simbo O. Aduloju MD
Premila Malhotra MD
Aaron R. Alizadeh MD
Ranjana S. Bhargava MD
Priya Rudolph
Kathleen E. Lambert MD

Pearlman Cancer Center at South Georgia Medical Center

2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

425 Third Avenue
Albany, GA 31702
(229) 312-0406
www.phoebehealth.com

University Cancer and Blood Center, LLC - Athens Medical Oncology

3320 Old Jefferson Road
Building 700
Athens, GA 30607
706-353-2990 x279
www.universitycancer.com

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.

About Us Research Resources & Education Screening & Genetics Clinical Trials & Providers Cancer Navigators Survivorship Media, News & Events Contact Us Donate Take Our Survey Link to Us

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.

Georgia's Online Cancer Information Center

Find A Clinical Trial