E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Small Cell Lung Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Non-Small Cell Lung Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ NSCLC. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to determine Duration of response (DoR), Disease control rate (DCR), Duration of disease control (DDC), Progression Free Survival (PFS), Overall Survival (OS), Safety and Tolerability. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically confirmed non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status), or histologically documented squamous cell NSCLC.
• Has locally advanced or metastatic NSCLC.
• Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory, or known documented MET gene amplification.
• Subjects with no documented MET gene amplification must submit archival or fresh tumor material for assessment of c-Met levels by an AbbVie designated IHC laboratory during the Pre-Screening period. If a subject meets eligibility criteria for c-Met protein expression level based on archival tumor material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to enrolment.
• Subjects with known documented MET gene amplification may prescreen. Archival or fresh tumor material (obtained at the same time as, or after, determination of MET amplification status) will need to be collected for testing of c-Met protein expression level by an AbbVie designated IHC laboratory prior to enrolment.
• Subjects who have progressed on systemic cytotoxic chemotherapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible for an immune checkpoint inhibitor), and prior anti-cancer therapies targeting driver gene alterations (if applicable).
• Subject must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the metastatic setting.
• Subjects should not have received prior cMET-targeted antibody-based therapies.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. |
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E.4 | Principal exclusion criteria |
• Has adenosquamous histology.
• Has received anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy as described in the protocol.
• Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:
- There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy.
- They are asymptomatic and off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.
• Has a clinically significant condition(s) described in the protocol.
• Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
• Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
• Subject must not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.
• Subjects must not have received any live vaccine within 30 days of the first dose of investigational product. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall Response Rate (ORR) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Overall response rate assessed by an independent central review according to RECIST, version 1.1.10 ORR will be defined as the proportion of subjects with a confirmed complete response (CR) or confirmed partial response (PR) based on RECIST, version 1.1. |
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E.5.2 | Secondary end point(s) |
1. Duration of Response (DoR)
2. Disease Control Rate (DCR)
3. Duration of Disease Control (DDC)
4. Progression-Free Survival (PFS)
5. Overall Survival (OS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Time from the subject's initial response (CR or PR) to first occurrence of radiographic progression determined by an independent central review (ICR) or death from any cause for the responders.
2. Percentage of subjects with best overall response of confirmed CR or PR, or stable disease (SD) for at least 12 weeks (2 tumor assessments) following enrolment, based on RECIST, version 1.1.
3. Time from initial subject's response of SD, PR or CR until first occurrence of radiographic progression determined by an ICR or death from any cause.
4. Time from subject's first dose of study drug until first occurrence of radiographic progression determined by an independent central review or death from any cause.
5. Time from subject's first dose of study drug until death from any cause. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
China |
Israel |
Japan |
Korea, Republic of |
Puerto Rico |
Russian Federation |
Switzerland |
Taiwan |
Turkey |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end-of-study is defined as the date of the last subject's last visit or date of last follow-up contact with the subject, whichever is later. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |