A study of SGN-B6A compared to Docetaxel in previously treated non-small cell lung cancer
Descrizione riassuntiva dello studio
As part of this clinical trial, we are investigating whether the investigational drug SGN-B6A is effective in lung cancer, what side effects it has, and whether it works better than the standard treatment with Docetaxel. Docetaxel is approved by Swissmedic for the treatment of various cancers. The brand name for Docetaxel is Taxotere/™.
(BASEC)
Intervento studiato
Patients who choose to participate and are deemed eligible based on the results of preliminary examinations will be randomly assigned to one of 2 groups and will receive the study medication, either the investigational drug SGN-B6A or Docetaxel. Both will be administered via an arm vein (intravenously/i.v.).
Patients receiving SGN-B6A will receive the drug on days 1 and 15 of a 4-week cycle in the clinic. Patients receiving Docetaxel will have a clinic visit every 3 weeks. For therapy monitoring, imaging procedures will be performed on all patients in the first 18 months once every 9 weeks and then every 3 months as long as the cancer disease is stable or has improved. For patients who discontinue the study medication, imaging procedures will continue to be performed until the cancer disease has progressed. Blood samples will be taken for safety and research purposes, as well as to check the disease status. During clinic visits, patients will be asked to complete questionnaires to assess quality of life and symptoms. A visit lasts about 1 to 2 hours.
After patients have completed the administration of the study medications, they will be contacted by the study staff about once every 3 months to find out how they are doing.
The total duration of a patient's participation in the clinical trial is up to 5 years.
(BASEC)
Malattie studiate
Lung cancer that has spread in the body or cannot be surgically removed and has been previously treated (metastatic non-small cell lung cancer (NSCLC))
(BASEC)
- Age ≥18 years at the time of consent - Histologically or cytologically confirmed diagnosis of non-small cell lung cancer that has spread in the body or cannot be surgically removed - Patients must have received only the following prior therapies and must have experienced progression or relapse within 6 months of the last dose: - Patients without known genomic alterations must have been treated with a platinum-based combination therapy and an anti-PD-(L)1 drug. - Patients with tumors that have certain treatable genomic alterations must have received at least 1 drug in addition to platinum-based chemotherapy for that genomic alteration. - Measurable disease - Performance status according to the Eastern Cooperative Oncology Group (ECOG) of 0 or 1 - Adequate hematological, liver, and kidney function - Patients must be willing to undergo contraception - Patients must be able to provide tumor tissue (either through an existing sample or a tumor biopsy) (BASEC)
Criteri di esclusione
- Estimated life expectancy of less than 3 months - Known allergies/hypersensitivities/intolerances or contraindications to taxanes, Docetaxel, or any of the components in SGN-B6A - Known diseases of the cerebral vessels, unstable angina, myocardial infarction, or other heart diseases within 6 months prior to study initiation - Known other malignancies within 3 years prior to study initiation or signs of residual disease from a previously diagnosed malignancy - Patients with respiratory diseases - Receipt of a live vaccine within 30 days prior to study initiation - Major surgery within 21 days or minor surgery within 7 days prior to study initiation - Uncontrolled diabetes mellitus - Known infections in the medical history, such as HIV or hepatitis B and C - Concurrent participation in another study (BASEC)
Luogo dello studio
Basilea, Berna, Chur, Losanna, Zurigo
(BASEC)
Sponsor
Alessandra Fedato Legal representative in CH for Pfizer AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Alessandra Fedato
+41 763885296
alessandra.fedato@clutterpfizer.comPfizer AG
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
18.07.2024
(BASEC)
ID di studio ICTRP
NCT06012435 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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) (BASEC)
Titolo accademico
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) (ICTRP)
Titolo pubblico
A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (ICTRP)
Malattie studiate
Carcinoma, Non-Small-Cell Lung (ICTRP)
Intervento studiato
Drug: sigvotatug vedotinDrug: docetaxel (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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
Exclusion Criteria:
- 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 (ICTRP)
non disponibile
Endpoint primari e secondari
Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel) in all participants and in participants whose tumors express high levels of integrin beta-6 (IB6-high);Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR) between the experimental and control arms in all participants and in the IB6-high subgroup (ICTRP)
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR between the experimental and control arms in all participants and in the IB6-high subgroup;Confirmed ORR per RECIST v1.1 by investigator assessment;PFS per RECIST v1.1 by investigator assessment;Duration of Response (DOR) per RECIST v1.1 by BICR;DOR per RECIST v1.1 by investigator assessment;Number of participants with adverse events (AEs);Mean score in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30);Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30;Mean score in physical functioning scores on the EORTC QLQ-C30;Change from baseline score in physical functioning scores on the EORTC QLQ-C30;Mean score in role functioning scores on the EORTC QLQ-C30;Change from baseline score in role functioning scores on the EORTC QLQ-C30;Mean scores in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13);Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13;Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30;TTD in physical functioning scores on the EORTC QLQ-C30;TTD in role functioning scores on the EORTC QLQ-C30;TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Medical Monitor;Seagen Trial Information Support, clinicaltrials@seagen.com, 866-333-7436, Seagen Inc., (ICTRP)
ID secondari
C5751002, 2023-503827-25-01, SGNB6A-002 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06012435 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile