SWOG clinical trial number
S1619
A Feasibility Trial of Neoadjuvant Cisplatin - Pemetrexed - Atezolizumab with Adjuvant Maintenance Atezolizumab in Resectable Malignant Pleural Mesothelioma
Closed
Phase
Accrual
100%
Abbreviated Title
Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab
Status Notes
This study will permanently close to Step 1 accrual effective May 1, 2020 at 11:59 p.m. Pacific.
Activated
11/03/2017
Closed
05/01/2020
Research committees
Lung Cancer
Treatment
Cisplatin
Surgery
Pemetrexed
Atezolizumab
Eligibility Criteria Expand/Collapse
STEP 1
Pt must have Stage I-III malignant resectable pleural mesothelioma, planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP).
Pt must have epithelioid or biphasic histology (no sarcomatoid histology). Core needle biopsy or surgical biopsy of the pleura via thoracoscopy and small thoracotomy required. Cytology only is not sufficient.
Pt must have CT of the chest/abdomen with contrast or FDG-PET/CT scan w/in 28 days prior to Step 1 reg.
Pt must have measurable or non-measurable disease by CT or MRI w/in 28 days prior to Step 1 reg. CT from combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Non-measurable disease must be assessed w/in 42 days prior to Step 1 reg.
Pt must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound w/in 42 days prior to Step 1 reg. At minimum, samples must be obtained from the mediastinal stations 4R, 7 (subcarinal), and 4L. Patient must be T1-3 and N0-N2 (single station).
Pt must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy w/in 28 days prior to Step 1 reg to rule out peritoneal disease spread.
Pt must have consultation with a surgeon w/in 21 days prior to Step 1 reg. The surgeon must confirm that the patient�s disease is resectable by pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) and that the patient is an appropriate candidate for the surgical procedures.
Pt must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma.
Pt must be >/= 18 years of age.
Pt must have PS 0 or 1 w/in 28 days prior to Step 1 reg.
Pts requiring hearing aids or reporting hearing loss must have audiogram w/in 28 days prior to Step 1 reg (and must not have hearing impairment >/= CTCAE Grade 2).
Pt must have not had any major surgery or radiation w/in 28 days prior to Step 1 reg (not incl. diagnostic thoracotomies and laparoscopies).
Pt must not have any anticancer therapy or investigational agent w/in 28 days prior to Step 1 reg.
Pt must have ANC >/= 1,500/mcl, Hemoglobin >/= 9 g/dl, and platelets >/= 100,000/mcl w/in 28 days prior to Step 1 reg.
Pt must have creatinine </= 1.5 x ULN and creatinine clearance >/= 45ml/min w/in 28 days prior to Step 1 reg.
Pt must have total bilirubin </= 1.5 x ULN and AST and ALT </= 3 x ULN w/in 28 days prior to Step 1 reg.
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, 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 three years.
Pts must not be pregnant or nursing. FCBP and men must have agreed to use an effective contraceptive method for the duration of study treatment and for 5 months after the last dose of atezolizumab.
Pt must NOT have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
Pt must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
Pt must not have severe infections w/in 28 days prior to Step 1 reg.
Pt must not have active autoimmune disease that has required systemic treatment in past two years.
Pt must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Pt must not have active tuberculosis.
Pt must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, or evidence of active pneumonitis.
Pt must not have active HBV infection (testing required w/in 28 days prior to reg).
Patient must not have active HCV infection (testing required w/in 28 days prior to reg).
Patient must NOT have a known positive test for HIV. Patients do not need to be screened for HIV.
Pts must not have significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction w/in 3 months prior to initiation of treatment, unstable arrhythmias, or unstable angina given the higher risks associated with surgical resection.
Pt must not receive live, attenuated influenza vaccine within 4 weeks prior to reg or at any time during the study and until 5 months after the last dose of atezolizumab.
Pt must be willing to have tissue specimens submitted for translational medicine.
Pt must be offered the opportunity to participate in tissue and blood banking for future studies.
STEP 2: SURGERY
Pt must have a CT of chest/abdomen with contrast or FDG-PET/CT scan w/in 28 days prior to Step 2 reg. Patients must not have evidence of progression per RECIST 1.1 or Modified RECIST for Pleural Tumors.
Pts planning to receive EPP must also be evaluated for appropriateness of RT by a Radiation Oncologist w/in 14 days prior to Step 2 reg.
Pt must have PS 0-1 w/in 28 days prior to Step 2 reg.
Pt must have postoperative predicted FEV1 > 35%, postoperative predicted DLCO > 35%, and VO2 max > 15/ml/kg/min w/in 28 days prior to Step 2 reg.
Pt must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during Step 1.
Pt must be registered to Step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapy.
STEP 3: MAINTENANCE
Pt must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing. Patients who received radiation therapy (RT) must be registered to Step 3 w/in 28 days after discontinuing RT. Patients who did not receive RT must be registered to Step 3 w/in56 days after surgery.
Pt must have a CT of chest/abdomen/pelvis with contrast or FDG-PET/CT scan w/in 28 days prior to Step 3 reg. Pt must not have evidence of progression per RECIST 1.1 or modified RECIST for pleural tumors.
Pt may have discontinued RT early due to toxicity or other reasons.
Pt must have PS 0-1 w/in 28 days prior to Step 3 reg.
Pt must have ANC > 1,500/mcl, hemoglobin > 9 g/dl, and platelets > 100,000/mcl w/in 28 days prior to Step 3 reg.
Pt must have creatinine < 1.5 x ULN w/in 28 days prior to Step 3 reg.
Pt must have total bilirubin </= 1.5 x ULN and AST and ALT </= 3 x ULN w/in 28 days prior to Step 3 reg.
Pt must have Stage I-III malignant resectable pleural mesothelioma, planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP).
Pt must have epithelioid or biphasic histology (no sarcomatoid histology). Core needle biopsy or surgical biopsy of the pleura via thoracoscopy and small thoracotomy required. Cytology only is not sufficient.
Pt must have CT of the chest/abdomen with contrast or FDG-PET/CT scan w/in 28 days prior to Step 1 reg.
Pt must have measurable or non-measurable disease by CT or MRI w/in 28 days prior to Step 1 reg. CT from combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Non-measurable disease must be assessed w/in 42 days prior to Step 1 reg.
Pt must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound w/in 42 days prior to Step 1 reg. At minimum, samples must be obtained from the mediastinal stations 4R, 7 (subcarinal), and 4L. Patient must be T1-3 and N0-N2 (single station).
Pt must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy w/in 28 days prior to Step 1 reg to rule out peritoneal disease spread.
Pt must have consultation with a surgeon w/in 21 days prior to Step 1 reg. The surgeon must confirm that the patient�s disease is resectable by pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) and that the patient is an appropriate candidate for the surgical procedures.
Pt must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma.
Pt must be >/= 18 years of age.
Pt must have PS 0 or 1 w/in 28 days prior to Step 1 reg.
Pts requiring hearing aids or reporting hearing loss must have audiogram w/in 28 days prior to Step 1 reg (and must not have hearing impairment >/= CTCAE Grade 2).
Pt must have not had any major surgery or radiation w/in 28 days prior to Step 1 reg (not incl. diagnostic thoracotomies and laparoscopies).
Pt must not have any anticancer therapy or investigational agent w/in 28 days prior to Step 1 reg.
Pt must have ANC >/= 1,500/mcl, Hemoglobin >/= 9 g/dl, and platelets >/= 100,000/mcl w/in 28 days prior to Step 1 reg.
Pt must have creatinine </= 1.5 x ULN and creatinine clearance >/= 45ml/min w/in 28 days prior to Step 1 reg.
Pt must have total bilirubin </= 1.5 x ULN and AST and ALT </= 3 x ULN w/in 28 days prior to Step 1 reg.
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, 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 three years.
Pts must not be pregnant or nursing. FCBP and men must have agreed to use an effective contraceptive method for the duration of study treatment and for 5 months after the last dose of atezolizumab.
Pt must NOT have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
Pt must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
Pt must not have severe infections w/in 28 days prior to Step 1 reg.
Pt must not have active autoimmune disease that has required systemic treatment in past two years.
Pt must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Pt must not have active tuberculosis.
Pt must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, or evidence of active pneumonitis.
Pt must not have active HBV infection (testing required w/in 28 days prior to reg).
Patient must not have active HCV infection (testing required w/in 28 days prior to reg).
Patient must NOT have a known positive test for HIV. Patients do not need to be screened for HIV.
Pts must not have significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction w/in 3 months prior to initiation of treatment, unstable arrhythmias, or unstable angina given the higher risks associated with surgical resection.
Pt must not receive live, attenuated influenza vaccine within 4 weeks prior to reg or at any time during the study and until 5 months after the last dose of atezolizumab.
Pt must be willing to have tissue specimens submitted for translational medicine.
Pt must be offered the opportunity to participate in tissue and blood banking for future studies.
STEP 2: SURGERY
Pt must have a CT of chest/abdomen with contrast or FDG-PET/CT scan w/in 28 days prior to Step 2 reg. Patients must not have evidence of progression per RECIST 1.1 or Modified RECIST for Pleural Tumors.
Pts planning to receive EPP must also be evaluated for appropriateness of RT by a Radiation Oncologist w/in 14 days prior to Step 2 reg.
Pt must have PS 0-1 w/in 28 days prior to Step 2 reg.
Pt must have postoperative predicted FEV1 > 35%, postoperative predicted DLCO > 35%, and VO2 max > 15/ml/kg/min w/in 28 days prior to Step 2 reg.
Pt must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during Step 1.
Pt must be registered to Step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapy.
STEP 3: MAINTENANCE
Pt must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing. Patients who received radiation therapy (RT) must be registered to Step 3 w/in 28 days after discontinuing RT. Patients who did not receive RT must be registered to Step 3 w/in56 days after surgery.
Pt must have a CT of chest/abdomen/pelvis with contrast or FDG-PET/CT scan w/in 28 days prior to Step 3 reg. Pt must not have evidence of progression per RECIST 1.1 or modified RECIST for pleural tumors.
Pt may have discontinued RT early due to toxicity or other reasons.
Pt must have PS 0-1 w/in 28 days prior to Step 3 reg.
Pt must have ANC > 1,500/mcl, hemoglobin > 9 g/dl, and platelets > 100,000/mcl w/in 28 days prior to Step 3 reg.
Pt must have creatinine < 1.5 x ULN w/in 28 days prior to Step 3 reg.
Pt must have total bilirubin </= 1.5 x ULN and AST and ALT </= 3 x ULN w/in 28 days prior to Step 3 reg.
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