Primary Site |
Sponsor/Study ID
NCT#
|
Protocol Description |
Eligibility |
IIIA, II or IB Resected
Non-Squamous NSCLC
|
NCI
A151216
ALCHEMIST
NCT02194738
|
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial
(ALCHEMIST)
This is the pre-registration study which randomizes to either A081105 or E4512
|
- ECOG PS: 0 or 1
- No neoadjuvant (chemo or radio-therapy) for this lung cancer
- No prior treatment with agents targeting EGFR mutation or ALK rearrangement
- Pre-surgical: Suspected clinical stage of IIIA, II or large IB (defined
as size ≥4cm)
- Post-surgical: Pathologic stage IIIA, II or IB (defined as size ≥4 cm)
- No recurrence of lung cancer after prior resection
|
IIIA, II or IB Resected
Non-Squamous
NSCLC
|
NCI
A081105
ALCHEMIST
NCT02193282
|
Randomized double blind placebo controlled study of erlotinib or placebo
in patients with completely resected epidermal growth factor receptor
(EGFR) mutant non-small cell lung center (NSCLC)
Effective 6/15/2020: temporary enrollment suspension for all patients.
|
- ECOG PS: 0 or 1
- Registered to A151216 with result of EGFR exon 19 deletion or L858R mutation
- Completely resected stage IB (≥ 4cm), II, or IIIA non-squamous NSCLC
with negative margins
-
Patients with known resistant mutations in the EGFR TK domain (T790M) are
not eligible.
-
Patients that are
both EGFR mutant and ALK rearrangements will be registered to A081105
|
IIIA, II or IB Resected Non-Squamous NSCLC
Adjuvant
|
NCI
EA5142
ALCHEMIST
NCT02201992
|
A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small
Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors
Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein |
- ECOG PS: 0 or 1
- Pre-registered to A151216
- Completely resected stage IB (≥4 cm), II or IIIA non-squamous NSCLC
with negative margins
- Positive for translocation or inversion events involving the ALK gene locus
- No prior treatment with crizotinib or another ALK inhibitor
- No known interstitial fibrosis or interstitial lung disease.
|
NSCLC Unknown EGFR status |
Biodesix
BDX-00146
NCT03289780
|
An Observational Study Assessing the Clinical Effectiveness of VeriStrat®
and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer |
- 18 years of age or older
- Diagnosis of NSCLC
- EGFR mutation status wildtype or unknown
- If prior treatment for local disease, then documented disease progression
and treatment completed prior to VeriStrat
|
NSCLC Stage III |
EMD Serono
MS200647_0005
NCT03840902
|
A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with
Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation
Plus Placebo Followed by Durvalumab in Participants with Unresectable
Stage III Non-small Cell Lung |
- Participants must have histologically documented NSCLC who present with
Stage III locally advanced, unresectable disease (International Association
for the Study of Lung Cancer Staging Manual in Thoracic Oncology
- Participants with tumor harboring an Epidermal growth factor receptor (EGFR)
sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation,
ROS-1 rearrangement are eligible.
- Participants must have adequate pulmonary function defined as a forced
expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2
liters or >= 50% of predicted normal volume measured within 3 weeks
prior to randomization.
- Adequate hematological, hepatic and renal function as defined in the protocol.
- Contraceptive use by males or females will be consistent with local regulations
on contraception methods for those participating in clinical studies.
|
NSCLC Stage III |
Merck
MK-7339-006
NCT03976323
|
A Phase III Study of Pembrolizumab in Combination with Pemetrexed/Platinum
(Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib
vs Maintenance Pemetrexed in the First-Line Treatment of Participants
with Metastatic Nonsquamous Non-Small-Cell Lung Cancer |
- Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
- Have stage IV nonsquamous NSCLC.
- Have confirmation that epidermal growth factor receptor (EGFR), anaplastic
lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed
therapy is not indicated.
- Have measurable disease based on RECIST 1.1.
- Have provided archival tumor tissue sample or newly obtained core or incisional
biopsy of a tumor lesion not previously irradiated.
- Have a life expectancy of at least 3 months.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology
Group (ECOG) Performance Status assessed within 7 days prior to the administration
of study intervention.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- Have adequate organ function.
- Male and female participants who are not pregnant and of childbearing potential
must follow contraceptive guidance during the treatment period and for
180 days afterwards.
- Male participants must refrain from donating sperm during the treatment
period and for 180 days afterwards.
|
NSCLC Stage III |
Merck
MK-7339-008
NCT03976362
|
A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane
(Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without
Maintenance Olaparib in the First-line Treatment of Metastatic Squamous
Non-small Cell Lung Cancer (NSCLC) |
- Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
- Have stage IV squamous NSCLC.
- Have measurable disease based on RECIST 1.1.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- Have provided archival tumor tissue sample or newly obtained core or incisional
biopsy of a tumor lesion not previously irradiated.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology
Group (ECOG) Performance Status assessed within 7 days prior to the administration
of study intervention.
- Have a life expectancy of at least 3 months.
- Have adequate organ function.
- Male and female participants who are not pregnant and of childbearing potential
must follow contraceptive guidance during the treatment period and for
180 days afterwards.
- Male participants must refrain from donating sperm during the treatment
period and for 180 days afterwards.
|
All Stages of Lung Cancer |
Fujirebio Diagnostics, Inc.
FDI-209
No NCT number
|
A Prospective Longitudinal Collection of Peripheral Blood to Support the
Validation of Biomarkers as an Aid in Monitoring Disease in Patients with
all Stages of Lung Cancer |
- Age ≥ 22 years
- Histologic/pathologic confirmation of lung cancer
- Any stage of disease
- Any treatment time point
- Individuals with a history of malignant disease other than lung cancer
that was resected greater than 5 yeaars ago and are currently in remission
are eligible
|
Limited Stage Small Cell Lung Cancer |
NRG Oncology
NRG-LU005
NCT03811002
|
Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized
Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab |
- Histologically or cytologically proven Limited stage SCLC
- Must have received one pre-reg cycle of platinum/etoposide chemo prior
to study entry
- PET/CT scan for staging and CT chest/abdomen with IV contrast (can be obtained
as part of PET/CT if diagnostic quality)
- ECOG 0-2 within 30 days prior to registration
- No prior atezolizumab or other immunotherapy agent
- No prior radiotherapy to the lungs or mediastinum that would result in
clinically significant overlap of radiation therapy fields
- Patients with cytologically positive pleural or pericardial fluid are not eligible
- No active, known or suspected autoimmune disease
- No Active or prior documented inflammatory bowel disease
- No Hx of primary immunodeficiency
- No clinically significant ILD
|
Stage 1 NSCLC |
JoLT-Ca
(Joint Lung Cancer Trialist’s Coalition)
STU 022015-069
|
A Randomized Phase III Study of Sublobular Resection (SR) versus Stereotactic
Ablative Radiotherapy (SAbR) in High Risk Patients with Stage I Non-Small
Cell Lung Cancer (NSCLC) |
- Primary tumor in the lung must be biopsy confirmed non-small cell lung cancer
- Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected
IB by PET/CT scan
- Tumor verified by a thoracic surgeon to be in a location that will permit
sublobar resection
- Tumor located peripherally within the lung
- No evidence of distant metastases
- Availability of pulmonary function tests
- No prior intra-thoracic radiation therapy for previously identified intra-thoracic
primary tumor
- Previous chemotherapy, radiotherapy, or surgical resection specifically
for the lung cancer being treated on this protocol is NOT permitted
- No prior lung resection on the ipsilateral side
|
Unresectable Stage III Non-Small Cell Lung Cancer |
Astra Zeneca
D4194C00008
NCT04381494
|
Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications
to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable
Stage III Non-Small Cell Lung Cancer Patients on Durvalumab |
- Patient has unresectable Stage III NSCLC that has not progressed following
concurrent platinum-based chemotherapy and radiation therapy and is eligible
to receive durvalumab according to the US FDA approved package insert.
- Patient will initiate durvalumab treatment within 2 weeks of Baseline and
receive at least 1 dose of durvalumab.
- Patient is able and willing to use the mobile application and connected
devices on a daily basis for up to 12 months.
- Patient is able to complete QoL assessments once every 2 weeks for the
first 3 months of the study and monthly thereafter.
|