Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Phase I Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)
iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung carcinoma (NSCLC) - stage IIIB/IV.
iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with
atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous NSCLC (stage
IIIB/IV). Patients will initially receive 4 cycles of ADI PEG20 in combination with
atezolizumab, pemetrexed and carboplatin unless there is documented disease progression or
unacceptable toxicities. On completion of 4 cycles and in the absence of disease progression
requiring other therapeutic interventions, patients may receive additional cycles of ADI
PEG20 and/or atezolizumab and/or pemetrexed for up to a maximum of 2 years at the discretion
of the treating physician.
Dose escalation will occur using a 3 + 3 design. The trial will start at dose level 1, which
represents 100% of the recommended dose of carboplatin (AUC5) and pemetrexed (500mg/m2) when
given as a combination, 100% of the atezolizumab recommended dose (1200mg) and 50% of the
recommended single agent dose of ADI PEG20 (18mg/m2). ADI PEG20 doses will be increased
according to pre-planned dose escalations.
If the maximum tolerated dose (MTD) is reached with the first 6 patients, up to an additional
6 patients will be enrolled at the MTD. The MTD is defined as the dose level below that at
which 2/3 or ≥3/6 patients experience a dose limiting toxicity (DLT).
The maximum administered dose (MAD) may also equal the MTD if dose escalation is stopped
before two DLTs are observed at a given dose level due to the expectation that higher dose
levels would be too toxic to administer to patients or the maximum planned dose level has
been achieved.
The MTD will be determined following review of all the relevant toxicity data by the Safety
Review Committee (SRC).
If dose level 1 equals the MAD then dose level -1 may be investigated with a 50% reduction in
ADI PEG20 (9mg/m2) along with atezolizumab 1200mg, carboplatin AUC5, and pemetrexed 500mg/m2.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |