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
  • Susan Metzger, 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
  • Susan Metzger, RN MSN 610-738-2515

NCCN TH-138

NCCN TH-138: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous Non Small Cell Lung Cancer patients who harbor a sensitizing EGFR mutation or have never smoked.

ClinicalTrials.gov Identifier: NCT 03786692

This study is a Collaboration between: F. Hoffmann-La Roche Ltd./Genentech (funding provided by pharmaceutical companies)
Supported by: National Comprehensive Cancer Network (NCCN)

Purpose:

The purpose of this research study is to discover if the combination of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in never smoker and sensitizing EGFR mutated non-small cell lung cancer (NSCLC) patients as compared to the combination without atezolizumab. Atezolizumab is a FDA approved drug for treatment of metastatic non-small cell lung cancer that has progressed following chemotherapy. Pemetrexed and bevacizumab are also approved by the FDA for treatment of non-small cell lung cancer. Carboplatin is commonly used to treat non-small cell lung cancer but a combination of carboplatin, pemetrexed, bevacizumab and atezolizumab is investigational for patients with NSCLC induced by EGFR mutation.

Treatment Arms:

  • Arm A: Experimental Care--Carboplatin + Pemetrexed + Bevacizumab + Atezolizumab
    Maintenance:  Pemetrexed + Bevacizumab + Atezolizumab  
  • Arm B: Standard Care--Carboplatin + Pemetrexed + Bevacizumab
    Maintenance: Pemetrexed + Bevacizumab

Follow Up:

Patients will be followed by phone call every 3 months for up to 5 years from the date of 100-days after treatment stopped.

Partial Eligibility Criteria:

  • Must have histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer
  • Must have either tumors that contain an EGFR mutation in exon 19 or exon 21, or must be never smoker. 
    • Never smoker patients must have smoked less than 100 cigarettes in a lifetime. 
    • Patients with an EGFR mutation in exon 19 or 21 may be included whether they have ever smoked or not. 
    • If tissue testing for EGFR mutation status is not available, blood-based EGFR testing that confirms presence of a mutation in exon 19 or 21 is acceptable, and these patients may be included in the study.

 For additional information please contact the Research nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, 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
  • Susan Metzger, RN, MSN; 610-738-2515
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