Informations générales (source: ClinicalTrials.gov)
A Randomized, Phase 3, Open-label Study to Evaluate Sigvotatug Vedotin Compared With Docetaxel in Adult Participants With Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01)
Interventional
Phase 3
Seagen Inc. (Voir sur ClinicalTrials)
février 2024
juillet 2028
16 octobre 2024
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC).
Participants in this study must have cancer that has spread through their body or can't
be removed with surgery. Participants in this study must have been treated with no more
than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors
that have certain treatable genomic alterations must have had at least 1 drug for that
genomic alteration, in addition to platinum-based chemotherapy.
This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type
of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill
them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer
drug that has been approved to treat non-small cell lung cancer. It is usually given to
patients who previously received another anticancer treatment. In this study, one group
of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A
second group of participants will get docetaxel on Day 1 during each 21-day cycle.
This study is being done to see if sigvotatug vedotin works better than docetaxel to
treat participants with NSCLC. This study will also test what side effects happen when
participants take these drugs. A side effect is anything a drug does to the body besides
treating the disease.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Cancerologie du Grand Montpellier - 34070 - Montpellier - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Cholet - 49300 - Cholet - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou - 35000 - Rennes - Other - France | Contact (sur clinicalTrials) | ||||
| Chits Sainte Musse - 83 000 - Toulon - Other - France | Contact (sur clinicalTrials) | ||||
| CHRU de Lille - 59037 - Lille - Other - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux Hopital Haut-Leveque - 33604 - Pessac - Other - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - hopital Larrey - 31059 - Toulouse - Other - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord Marseille - 13015 - Marseille - Other - France | Contact (sur clinicalTrials) | ||||
| Hospital Center De Cornouaille - 29 107 - Quimper Cedex - Other - France | Contact (sur clinicalTrials) | ||||
| Institut de cancerologie Strasbourg Europe - 67200 - Strasbourg - Other - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Besancon - 25030 - Besancon Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of locally advanced,
unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC
American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union
for International Cancer Control (UICC) Staging System (Eighth edition).
- Participants must have NSCLC with nonsquamous histology
- Tumors with squamous, or predominantly squamous histology are excluded.
- Tumors with small cell elements are excluded.
- Participants who have NSCLC with known actionable genomic alteration (AGAs) are
permitted
- Participants must have received the following prior therapies and progressed during
or relapsed after receiving their most recent prior therapy:
- Participants with no known AGAs must fulfill 1 of the following conditions:
- Received a platinum-based combination therapy for the treatment of
metastatic or recurrent disease and a PD-(L)1 monoclonal antibody
(concurrently or sequentially with platinum-based chemotherapy), unless
contraindicated.
- Experienced disease progression within 6 months of the last dose of
platinum-based chemotherapy in the adjuvant or neoadjuvant setting and
received a PD-(L)1 monoclonal antibody at any time during the course of
treatment.
- Participants with known AGAs must fulfill the following conditions:
- Must have received at least 1 relevant AGA targeted therapy and in the
opinion of the investigator, additional AGA targeted therapy is not in the
best interest of the participant.
- Received a platinum-based combination therapy for the treatment of
metastatic or recurrent disease, or experienced disease progression within
6 months of the last dose of platinum-based chemotherapy in the adjuvant
or neoadjuvant setting
- May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or
sequentially with platinum-based chemotherapy).
- Measurable disease based on RECIST v1.1
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function
and measurable disease according to RECIST v1.1
- Histologically or cytologically confirmed diagnosis of locally advanced,
unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC
American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union
for International Cancer Control (UICC) Staging System (Eighth edition).
- Participants must have NSCLC with nonsquamous histology
- Tumors with squamous, or predominantly squamous histology are excluded.
- Tumors with small cell elements are excluded.
- Participants who have NSCLC with known actionable genomic alteration (AGAs) are
permitted
- Participants must have received the following prior therapies and progressed during
or relapsed after receiving their most recent prior therapy:
- Participants with no known AGAs must fulfill 1 of the following conditions:
- Received a platinum-based combination therapy for the treatment of
metastatic or recurrent disease and a PD-(L)1 monoclonal antibody
(concurrently or sequentially with platinum-based chemotherapy), unless
contraindicated.
- Experienced disease progression within 6 months of the last dose of
platinum-based chemotherapy in the adjuvant or neoadjuvant setting and
received a PD-(L)1 monoclonal antibody at any time during the course of
treatment.
- Participants with known AGAs must fulfill the following conditions:
- Must have received at least 1 relevant AGA targeted therapy and in the
opinion of the investigator, additional AGA targeted therapy is not in the
best interest of the participant.
- Received a platinum-based combination therapy for the treatment of
metastatic or recurrent disease, or experienced disease progression within
6 months of the last dose of platinum-based chemotherapy in the adjuvant
or neoadjuvant setting
- May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or
sequentially with platinum-based chemotherapy).
- Measurable disease based on RECIST v1.1
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function
and measurable disease according to RECIST v1.1
- Life expectancy of less than (<) 3 months
- Known allergies/hypersensitivity/intolerance to or contraindication of taxanes,
docetaxel, or any excipient contained in the drug formulation of sigvotatug vedotin
- History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence
of residual disease from a previously diagnosed malignancy. Exceptions are
malignancies with a negligible risk of metastasis or death
- Participants with any of the following respiratory conditions:
- Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
- Was previous diagnosed and required systemic steroids, or
- Is currently diagnosed and managed, or
- Is suspected on radiologic imaging at screening
- Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50%
- Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to
underlying malignancy
- Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
- Uncontrolled diabetes mellitus
- Prior therapy:
- Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or
MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
- Prior antimicrotubule agent exposure in curative settings (including adjuvant,
neoadjuvant, or chemoradiotherapy) is permissible.
- Received more than 1 prior line of cytotoxic chemotherapy in the locally
advanced, unresectable/refractory, or metastatic setting
- Prior cytotoxic chemotherapy in curative settings is permissible
- At least 14 days must have elapsed from the last dose of radiotherapy until
Cycle 1 Day 1.
- Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6
months of Cycle 1 Day 1.
- Any systemic anticancer therapy (standard or experimental) within 21 days prior
to Cycle 1 Day 1.
- Active central nervous system (CNS) lesions, including leptomeningeal metastasis,
are excluded. Participants with definitively treated brain metastases are eligible
in they meet the following criteria:
- Have been clinically stable for at least 4 weeks prior to treatment initiation
and baseline scans show no evidence of new or enlarged metastasis
- On a stable dose of less than or equal to (≤) 10mg/day of prednisone or
equivalent for a least 2 weeks (if requiring steroid treatment)
- Treatment with corticosteroids greater than (>) 1 month prior to Screening
visit
- No evidence of clinical and radiographic disease progression in the CNS for ≥
21 days after definitive radiotherapy and/or surgery