Alchemist Study A081105

A081105: 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)

Purpose:

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

This research study has two study groups.  You will be "randomized" into one of two study groups in the study. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups.  Neither you nor your doctor can choose the group you will be in.  You will have an equal chance of being placed in any group.

ARM I:
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 II:
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.

Follow Up:

After completion of study treatment, patients are followed up every 6 months for 5 years.

Partial Eligibility Criteria:

  • Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins
  • Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation

For additional information, please contact the Research nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • CarolAnn Hoppes, RN, MSN; 610-738-2515

Alchemist Sub Study A151216

A151216: Genetic Testing in Screening Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

Purpose:

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors choose the best treatment for patients that have certain genetic changes.

The goals of the study include to centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies and to obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).

Patients will undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.

Follow Up:

After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

Partial Eligibility Criteria:

  • Completely resected non-small cell lung cancer; patients with squamous cell carcinoma 
  • Pathologic stage IIIA, II or IB (defined as size >= 4 cm)
  • No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
  • No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas; a secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216
  • No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4

 For additional information please contact the Research nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • CarolAnn Hoppes, RN, MSN; 610-738-2515

Alchemist Sub Study E4512

ECOG E4512: Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

Purpose:

This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known whether crizotinib may be an effective in treating non-small cell lung cancer with an ALK fusion mutation.

This research study has two study groups. You will be "randomized" into one of two study groups in the study. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in.  You will have an equal chance of being placed in any group.

ARM A: 
Patients receive crizotinib orally (PO) twice daily (BID) 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: 
Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Follow Up:

After completion of study treatment, patients are followed up periodically for 10 years.

Partial Eligibility Criteria:

  • Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
  • Positive for translocation or inversion events involving the ALK gene locus
  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA

For additional information, please contact the Research nurses:

  • Nona Blauvelt RN MSN AOCN 610-738-2522
  • CarolAnn Hoppes RN MSN 610-738-2515

ECOG/ACRIN EA5142

EA5142: Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab after Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Purpose:

The purpose of this study is to find if adding the study drug, nivolumab (also known as OPVIDO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer (NSCLC). Nivolumab is a drug that may turn on the body's immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.

This research study has two study groups.  You will be "randomized" into one of two study groups in the study. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in.  You will have an equal chance of being placed in any group.

Group 1
Patients will receive the study drug, nivolumab. Nivolumab is administered by an intravenous (IV) infusion over 30 minutes once every two weeks. Treatment will continue for a maximum of 1 year or 26 doses of nivolumab or until you have side effects, your cancer returns, or you decide to stop.

Group 2 
Patients will be monitored with standard post-operative follow-up treatment. 

Follow Up:

After completion of study treatment, patients are followed for up to 10 years. (Both groups will include CT scans of the chest.)

Partial Eligibility Criteria:

  • Patients must have undergone complete surgical resection of their stage IB, II or IIIA
  • Patients must  have completed and recovered from any adjuvant chemotherapy and radiation therapy
  • Patients must NOT have uncontrolled illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, autoimmune disease, HIV, Hepatitis B or C infection, any other active second cancer diagnosis or psychiatric illness/social situation that would limit compliance with study requirements
  • Patients must not be receiving any other investigational anti-cancer agents while on study
  • Women must not be pregnant or breast-feeding
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

For additional information, please contact the Research Nurses: 

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • CarolAnn Hoppes, RN, MSN; 610-738-2515

SWOG S1400 Lung Map Study

Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer

Brief Summary:

The Lung-MAP study is an umbrella protocol which contains a screening component and a treatment component.

The screening component may occur either while receiving therapy for stage IV or recurrent NSCLC or at progression.

The treatment component consists of targeted drug therapy evaluating matching tumor biomarker combinations for patients determined to have a biomarker and non-match studies evaluating therapies in patients without any of biomarkers. 

Treatment Arms:

The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies

Follow-Up:

For up to 3 years 

Partial Eligibility Criteria:

  • Pathologically proven(NSCLC) non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration.
  • Disease must be Stage IV or recurrent. 

Final eligibility assessment is done by the health care professionals associated with the trial.

For additional information, please contact the Research nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • CarolAnn Hoppes, RN, MSN; 610-738-2515
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