Open Trials
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A multicentre single-arm phase II trial of amivantamab, lazertinib plus bevacizumab in patients with EGFR-mutant advanced NSCLC with progression on previous third-generation EGFR-TKI.
AMAZE-lung: Amivantamab, lazertinib and bevacizumab in patients with EGFR-mutant advanced non-small cell lung cancer with progression on previous third-generation EGFR-TKI
The AMAZE-lung study aims to test the efficacy of amivantamab, bevacizumab and lazertinib in patients with EGFR-mutant advanced NSCLC.
Trial Scheme
| Primary Endpoint: | Objective response rate (ORR), investigator assessed, at 12 weeks according to RECIST v1.1 |
| Secondary Endpoints: |
Duration of response (DoR) Progression-free survival (PFS) according to RECIST v1.1 Disease control rate (DCR) according to RECIST v1.1 Overall survival (OS) Safety and tolerability (CTCAE v5.0) |
| Target Sample Size: | 60 enrolled patients |
| Protocol Release Date: | 14 September 2022 |
Trial Organisation |
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| Trial Chair: | Ross Soo, Singapore |
| Trial Co-Chair: |
Sanjay Popat, London, United Kingdom |
| Sponsor: | ETOP IBCSG Partners Foundation |
| Coordinating Group: | ETOP IBCSG Partners Foundation |
| Participating Groups: | Spanish Lung Cancer Group (SLCG) |
| Participating Countries: |
France, Italy, the Netherlands, Singapore, South Korea, Spain, Switzerland, United Kingdom |
| Registrations: |
EudraCT number: 2021-002337-42 clinicaltrials.gov: NCT05601973 |
Contact
Uli Kodjadjiku (Clinical Trial Manager)
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
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A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancer.
STEREO: Osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR mutant NSCLC
The trial explores the safety and efficacy of osimertinib treatment and locally ablative radiotherapy to all cancer sites, in patients with synchronous oligo-metastatic EGFR-mutant NSCLC.
Trial Scheme
| Primary Endpoint: | Rate of grade ≥2 pneumonitis, requiring medical treatment, observed any time during the first 18 months of follow-up from enrolment, in the primary-endpoint safety cohort. If safety is proven, efficacy will be hierarchically tested in terms of PFS according to RECIST v1.1, in the efficacy cohort. |
| Secondary Endpoints: |
Overall survival Pattern of disease progression Distant progression-free survival Objective response rate Duration of response Toxicity by CTCAE v5.0 Symptom-specific and global quality of life |
| Target Sample Size: | 60 enrolled patients |
| Protocol Release Date: | 26 April 2020 |
| Trial Activation Date: | 19 November 2021 |
Trial Organisation |
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| Trial Chair: | Matthias Guckenberger, Zürich, Switzerland |
| Trial Co-Chairs: |
Egbert F. Smit, Amsterdam, the Netherlands Cho Byoung Chul, Seoul, South Korea |
| Sponsor: | ETOP IBCSG Partners |
| Coordinating Group: | ETOP IBCSG Partners |
| Participating Group: | SLCG |
| Participating Countries: |
Europe: Italy, the Netherlands, Poland, Spain, Sweden, and Switzerland Asia: Singapore and South Korea |
| Registrations: |
EudraCT number: 2020-004114-35 clinicaltrials.gov: NCT04908956 |
Contact
Robin Schweri (Clinical Trial Manager)
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
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A multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligo-symptomatic brain metastases.
USZ-STRIKE: Immunotherapy or targeted therapy with or without stereotactic radiosurgery for patients with brain metastases from melanoma or non-small cell lung cancer
The trial aims to assess the efficacy of standard systemic treatment plus stereotactic radiosurgery in patients with newly diagnosed brain metastases from melanoma or NSCLC.
Trial Scheme
| Primary Endpoint: | CNS-specific PFS, locally assessed as per iRANO criteria |
| Secondary Endpoints: |
CNS-specific PFS per tumour cohort, locally assessed as per iRANO criteria CNS-specific PFS, overall and per tumour cohort, centrally assessed as per iRANO criteria Objective CNS-response rate, centrally assessed as per iRANO criteria Duration of CNS-response Pattern of CNS-specific progression (local versus distant progression) Extra-CNS progression, locally assessed as per RECIST v1.1 Incidence of radio-necrosis and pseudo-progression in the CNS OS, overall and per tumour cohort Neurocognitive function Quality of life and functional independence Toxicity by CTCAE v5 |
| Target Sample Size: | 190 randomised patients |
| Protocol Release Date: | 14 February 2022 |
Trial Organisation |
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| Trial Chair: | Michael Weller |
| Trial Co-Chairs: | Rolf Stahel |
| Sponsor: | ETOP IBCSG Partners Foundation |
| Coordinating Group: | ETOP IBCSG Partners Foundation |
| Participating Countries: |
Italy, the Netherlands, Switzerland, and United Kingdom |
| Registrations: | NCT05522660 |
Contact
Robin Schweri (Clinical Trial Manager)
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
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A multicentre, single-arm phase II trial of adagrasib in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status.
ADEPPT: Adagrasib in patients with KRASG12C-mutant NSCLC who are elderly or have poor performance status
The aim of the trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C‑mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).
Trial Scheme
| Primary Endpoint: | Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks |
| Secondary Endpoints: |
Durable clinical benefit Time to progression Progression-free Survival Overall Survival Safety Patient-related outcomes |
| Target Sample Size: | 68 enrolled patients |
| Protocol Release Date: | 15 July 2022 |
Trial Organisation |
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| Trial Chair: | Jarushka Naidoo, Dublin, Ireland |
| Trial Co-Chairs: |
Colin Lindsay, Manchester, United Kingdom Bartomeu Massuti, Alicante, Spain |
| Sponsor: | ETOP IBCSG Partners Foundation |
| Coordinating Group: |
ETOP IBCSG Partners Foundation, in collaboration with Cancer Trials Ireland (CTI) and the Spanish Lung Cancer Group (SLCG) |
| Participating Countries: |
Belgium, France, Ireland, Italy, Spain, and United Kingdom |
| Registrations: |
EudraCT number: 2022-002736-31 clinicaltrials.gov: TBD |
Contact
Virginia Rodriguez Martinez (Clinical Trial Manager)
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
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A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy and stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the primary tumour, in patients with synchronous oligo-metastatic non-small cell lung cancer
CHESS: Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC
Immunotherapy has substantially improved the outcome in metastatic NSCLC and has become first-line treatment of choice in patients with high PD-L1 expression and without EGFR or ALK mutations. However, only about one-third of NSCLC patients present a PD-L1 expression of ≥50%, excluding most patients from first-line immunotherapy. Various strategies are currently pursued to increase the number of patients that may benefit from immunotherapy and to further improve the outcome of patients with metastatic NSCLC.
The CHESS trial builds on encouraging data from combined chemo-radiotherapy with immune-checkpoint inhibitors and the excellent local control provided by radiotherapy and surgery.
Trial Scheme
| Primary Endpoint: | Progression-free survival at 12 months |
| Secondary Endpoints: |
Overall survival Pattern of disease progression Distant progression-free survival Response to induction therapy Overall response Duration of response Toxicity before and after surgery/radiotherapy Symptom-specific and global quality of life |
| Target Sample Size: | 47 patients |
| Protocol Release Date: | 25 April 2019 |
| Trial Activation Date: | 05 September 2019 |
| First Patient In: | 19 November 2019 |
Trial Organisation |
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| Trial Chair: | Matthias Guckenberger |
| Trial Co-Chair: | Isabelle Schmitt-Opitz |
| Sponsor: | ETOP IBCSG Partners |
| Coordinating Group: | ETOP IBCSG Partners |
| Participating Groups: | SAKK and SLCG |
| Participating Countries: |
Italy, The Netherlands, Spain, and Switzerland |
| Registrations: |
EudraCT number: 2018-003011-22 ClinicalTrials.gov: NCT03965468 |
Contact
Robin Schweri (Clinical Trial Manager)
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
