October 17, 2019 Lung

Research & Trial Information


Protocol#: NRG – LU003

Cancer Type: Non-Squamous Non-Small Cell Lung Cancer

Protocol Eligibility:

  1. Patients must have histologically or cytologically confirmed stage IV ALK-positive non-squamous NSCLC (includes M1a, M1b, M1c stage disease) ALK rearrangement must have been demonstrated by an FDA approved assay (Vysis FISH or Ventana IHC) or by next generation sequencing (NGS).
  2. Patient must be willing and able to undergo a fresh biopsy or if patient has a biopsy after progression on current TKI (and has continued TKI for clinical benefit per treating physician) this tissue may be used. Must have sufficient tissue.
  3. Age ≥ 18.
  4. Patient must have progressive disease.
  5. Patients who have received a cycle of chemotherapy at the time of original diagnosis of metastatic NSCLC are eligible as long as they have received a next generation ALK inhibitor.
  6. Patients with asymptomatic treated or untreated brain metastases are eligible. Treated brain metastases are eligible as long as patients have measurable disease outside the brain. Patients must be on a stable or decreasing dose of steroids for at least 7 days prior to step 2 registration. Anticonvulsants are allowed as long as the patient is neurologically stable and not deteriorating.
  7. Patients enrolled with asymptomatic brain mets must have at least one measurable target extracranial lesion.
  8. ECOG performance status 0-2.
  9. No major surgery within 2 weeks of study entry.Minor surgical procedures (eg, port insertion, pleurex catheter placement) are allowed and all wounds must not show signs of infection or draining.
  10. No radiation therapy (except palliative RT to relieve bone pain) within 2 weeks of study entry. Palliative RT (<10 fractions) must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 1 week prior to study entry. Whole brain RT must have completed at least 2 weeks prior to study entry.
  11. No prior dose of next generation ALK inhibitor (LDK378 (ceritinib), alectinib, ensartinib, lorlatinib] within 5 days prior to step 2 registration. Prior dose of brigatinib within 7 days prior to step 2 registration.
  12. Patients must not plan to receive any other investigational agents during the course of therapy.
  13. Patients with active malignancy other than ALK-positive non-squamous NSCLC within the last 2 years are excluded (note: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid cancer treated with curative intent, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 2 years are eligible).
  14. No chemotherapy and/or immunotherapy allowed after step 1 registration.

October 17, 2019 Lung

Research & Trial Information


Protocol#: ECOG – EA5163

Cancer Type: Advanced Nonsquamous Non-Small Cell Lung Cancer

Patient Eligibility:

  1. Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC. Patients with T4NX disease (Stage IIIB and IIIC) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation.

  2. Patients must have PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patients are not eligible.

  3. Patients must have measurable or non-measureable disease.
  4. Patients must be 18 years of age.
  5. Patients must have an ECOG Performance Status of 0 to 1.
  6. Patients must NOT have received the following:

    Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy for non-metastatic disease (e.g. adjuvant therapy) or immunotherapy for locally advanced Stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 14 days has passed between completion of local therapy and study registration. Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.

  7. Patients with known EGFR mutations (except exon 20 insertion), \BRAF mutations (V600) or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.

  8. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.

  9. Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

  10. Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

  11. Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

October 17, 2019 Lung

Research & Trial Information


Protocol#: ECOG – E4512

Cancer Type: Non-Small Cell Lung Cancer

Patient Eligibility:

  1. Age ≥ 18 years.
  2. Patients must have undergone complete surgical resection of their stage IB (≥ 4 cm), II, or non-squamous IIIA NSCLC and have had negative margins. N3 disease is not allowed.

  3. Baseline Chest CT with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease. If clinically indicated additional imaging studies must be performed to rule out metastatic disease.

  4. ECOG performance status 0 or 1.
  5. Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization.

  6. Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion).

  7. No prior treatment with crizotinib or another ALK inhibitor.
  8. Patients must be adequately recovered from surgery at the time of randomization.  The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days).

  9. The maximum time requirement between surgery and randomization must be:

    • 3 months (90 Days) if no adjuvant chemotherapy was administered

    • 8 months (240 Days) if adjuvant chemotherapy was administered

    • 10 months (300 Days) if adjuvant chemotherapy and radiation therapy were administered.

  10. Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization.

  11. Patients must not have any history of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer. Patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 years.

  12. Patients may not be receiving any other investigational agents while on study.

October 17, 2019 Lung

Research & Trial Information


Protocol#: NRG-CC003

Cancer Type: Small Cell Lung Cancer

Protocol Eligibility:

  1. Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC.
  2. High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
  3. Patients must be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy.
  4. Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration.
  5. For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
  6. Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan.
  7. Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:a. History/physical examination;b. CT of the chest and abdomen with contrast (does not have to be done if the patient has had a PET/CT scan prior to initiating chemotherapy or thoracic radiotherapy);c. MRI of the brain with contrast or diagnostic head CT with contrast;

    d. For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC.

  8. After chemotherapy, patients must be restaged prior to Step 1 registration using the same diagnostic work-up as required pre-chemotherapy. Repeat PET/CT or bone scan is not required.
  9. Zubrod performance status 0-2
  10. Age ≥18.
  11. No prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
  12. No radiographic evidence of CNS metastases.
  13. No planned concurrent chemotherapy during PCI, concurrent atezolizumab permitted.
  14. No concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
  15. No contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia.
  16. No severe, active comorbidity.

October 17, 2019 Lung

Research & Trial Information

SCHEMA A221504

Protocol#: Alliance – A221504

Cancer Type: Non-Small Cell Lung Cancer

Patient Eligibility:

1.  Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the primary or metastatic site.

2. No known presence of known EGFR or EML4-ALK driver mutations in the tumor.

3. Started first-line systemic therapy of the investigator’s choice within 12 weeks prior to registration, or planning to initiate first-line systemic therapy of the investigator’s choice within 4 weeks after registration. No planned initiation of definitive (potentially curative) concurrent chemo-radiation.

4. No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy (other than current treatment). Prior palliative radiation permitted; prior adjuvant systemic therapy /radiation is permitted.

5. No more than 7 days of prior use of mixed opioid agonist/opioid antagonists or other opioid antagonists within 4 weeks before registration. Patients should not receive such medications after registration and for the entire duration of study treatment.

6. No methadone within 4 weeks prior to registration.

7. Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration. Current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required.

8. Expected survival > 3 months.

9. No concurrently active second invasive malignancies except non-melanoma skin cancer.

10. No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall. No abdominal surgery within 60 days of registration.

11. No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer’s disease, or uncontrolled seizures).

12. Age ≥ 18 years.

13. ECOG Performance Status 0-2


October 16, 2019 Lung

Research & Trial Information

SCHEMA 30610

Protocol#: CALGB – 30610/RTOG – 0538

Cancer Type: Small Cell Lung Cancer

Patient Eligibility:

  1. Histologically or cytologically documented small cell lung cancer.
  2. Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes.
    • Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible.
    • Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible unless they have a negative throacentesis.
    • Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible
  3. Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan.
  4. Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide.
  5. Age ≥ 18 years of age.
  6. PS = 0-2.

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