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A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Non Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Telisotuzumab Vedotin

Docetaxel

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring c-Met Overexpressing Non-Small Cell Lung Cancer, c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Docetaxel, Cancer, Non Small Cell Lung Cancer, NSCLC, TeliMET NSCLC-01, Teliso-V

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
- If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
A known epidermal growth factor receptor (EGFR) activating mutation status.
Actionable alterations in genes other than EGFR .
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
- Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
  - Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
Participants 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 2 weeks after definitive therapy.
- They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.

Exclusion Criteria:

Participants with adenosquamous histology.
Actionable epidermal growth factor receptor (EGFR) activating mutations.
Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
Participants who have received prior docetaxel therapy.
A history of other malignancies except:
- Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without current evidence of disease.
A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
Clinically significant condition(s) as listed in the protocol.

Sites / Locations

The Oncology Institute of Hope and Innovation - DTLA /ID# 239774Recruiting
Eisenhower Medical Center /ID# 233189Recruiting
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228Recruiting
Kaiser Permanente Moanalua Medical Center /ID# 238363Recruiting
Edward-Elmhurst Cancer Center /ID# 238552Recruiting
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190Recruiting
Hattiesburg Clinic /ID# 248033Recruiting
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567Recruiting
Hulston Cancer Center /ID# 232226Recruiting
Renown Medical Group - Oncology/Hematology /ID# 247942Recruiting
San Juan Oncology Associates /ID# 244387Recruiting
Maimonides Medical Center /ID# 240783Recruiting
First Health of the Carolinas /ID# 241279Recruiting
Genesis Cancer Care Center /ID# 239190Recruiting
Avera Cancer Institute /ID# 239635Recruiting
Valley Medical Center /ID# 253950Recruiting
Centro Médico Austral /ID# 239860Recruiting
Cenit /Id# 239880Recruiting
Hospital Britanico de Buenos Aires /ID# 231495Recruiting
Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339Recruiting
Barwon Health /ID# 241920Recruiting
Austin Health /ID# 247507Recruiting
Ordensklinikum Linz GmbH Elisabethinen /ID# 240967Recruiting
Klinikum Wels-Grieskirchen GmbH /ID# 249000Recruiting
Landeskrankenhaus Feldkirch /ID# 250333Recruiting
Medizinische Universitaet Wien /ID# 230615Recruiting
Klinik Penzing /ID# 230700Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467Recruiting
Universitair Ziekenhuis Antwerpen /ID# 239971Recruiting
Grand Hopital de Charleroi /ID# 234178Recruiting
AZ Klina /ID# 239853Recruiting
Pôle Hospitalier Jolimont /ID# 246771Recruiting
CHU UCL Namur - Sainte Elisabeth /ID# 246769Recruiting
Ensino e Terapia de Inovacao Clínica AMO - Etica /ID# 231604Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 233249Recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 231509Recruiting
Instituto D'or de Pesquisa e Ensino /ID# 233245Recruiting
Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417Recruiting
Casa de Saúde Santa Marcelina /ID# 231605Recruiting
Complex Oncology Center - Burgas /ID# 240532Recruiting
UMHAT Sofiamed /ID# 234108Recruiting
UMHAT Sveta Marina /ID# 234112Recruiting
Clinica Universidad Catolica del Maule /ID# 231294Recruiting
Icegclinic /Id# 231212Recruiting
Sociedad Prosalud Montes y Orlandi /ID# 231154Recruiting
Fundacion Arturo Lopez Perez /ID# 231151Recruiting
Sociedad Oncovida /ID# 231152Recruiting
Anhui Chest Hospital /ID# 231899Recruiting
Peking Union Medical College Hospital /ID# 233175Recruiting
Beijing Chest Hospital, Capital Medical University /ID# 232202Recruiting
Fujian Provincial Cancer Hospital /ID# 243134Recruiting
The First Affiliated Hospital of Xiamen University /ID# 242381Recruiting
The First Affiliated Hospital of Guangzhou Medical University /ID# 238591Recruiting
Cancer Hospital of Shantou University Medical College /ID# 242182Recruiting
Affiliated Hospital Of Guangdong Medical University /ID# 233317Recruiting
Guizhou Provincial People's Hospital /ID# 243614Recruiting
Affiliated Hospital of Hebei University /ID# 239586Recruiting
Harbin Medical University Cancer Hospital /ID# 231941Recruiting
The First affiliated Hospital of Nanyang Medical College /ID# 244652Recruiting
Henan Provincial People's Hospital /ID# 242187Recruiting
Henan Cancer Hospital /ID# 239577Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904Recruiting
Tongji Hospital Tongji Medical College of HUST /ID# 239575Recruiting
Hubei Cancer Hospital /ID# 240045Recruiting
Nanjing Drum Tower Hospital /ID# 231791Recruiting
Nantong Tumor Hospital /ID# 232424Recruiting
The First Affiliated Hospital of Nanchang University /ID# 231934Recruiting
The Second Affiliated Hospital of Nanchang University /ID# 231935Recruiting
The First Hospital of China Medical University /ID# 231924Recruiting
Jinan Central Hospital /ID# 231895Recruiting
Shandong Cancer Hospital /ID# 251506Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023Recruiting
Sichuan Cancer Hospital /ID# 239707Recruiting
West China Hospital, Sichuan University /ID# 233703Recruiting
Tianjin Medical University Cancer Institute and Hospital /ID# 233176Recruiting
Zhejiang Cancer hospital /ID# 242476Recruiting
Taizhou Hospital, Zhejiang Province /ID# 232021Recruiting
The Second Hospital of Dalian Medical University /ID# 239755Recruiting
Linyi Cancer Hospital /ID# 239713Recruiting
Ningbo No. 2 Hospital /ID# 242478Recruiting
Shanghai Chest Hospital /ID# 231897Recruiting
Tianjin Medical University General Hospital /ID# 231839Recruiting
Masarykuv onkologicky ustav /ID# 232426Recruiting
Nemocnice AGEL Novy Jicin, a.s. /ID# 232427Recruiting
Odense University Hospital /ID# 241663Recruiting
CHU Bordeaux - Hopital Haut Leveque /ID# 244953Recruiting
Hopital Arnaud de Villeneuve /ID# 239404Recruiting
AP-HP - Hopital Cochin /ID# 239409Recruiting
AP-HP - Hopital Tenon /ID# 239179Recruiting
Universitatsklinikum Mannheim /ID# 238331Recruiting
Universitaetsklinikum Jena /ID# 239661Recruiting
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 239658Recruiting
Thoraxklinik Heidelberg gGmbH /ID# 239656Recruiting
Klinikum Kassel /ID# 240142Recruiting
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824Recruiting
Metropolitan Hospital /ID# 239170Recruiting
The Edith Wolfson Medical Center /ID# 233781Recruiting
Ziv Medical Center /ID# 238606Recruiting
Azienda Ospedaliera San Giovanni Addolorata /ID# 238618Recruiting
Azienda Ospedaliera di Perugia /ID# 238473Recruiting
I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696Recruiting
Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698Recruiting
ASST Sette Laghi /ID# 238536Recruiting
NHO Nagoya Medical Center /ID# 246306Recruiting
Nagoya University Hospital /ID# 239990Recruiting
Hirosaki University Hospital /ID# 242377Recruiting
National Cancer Center Hospital East /ID# 233775Recruiting
National Hospital Organization Kyushu Medical Center /ID# 238533Recruiting
Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191Recruiting
Fukushima Medical University Hospital /ID# 249691Recruiting
Gunma Prefectural Cancer Center /ID# 233723Recruiting
Chugoku Central Hospital /ID# 242970Recruiting
Hiroshima University Hospital /ID# 241882Recruiting
Hokkaido University Hospital /ID# 241289Recruiting
Kobe Minimally Invasive Cancer Center /ID# 254131Recruiting
Takarazuka City Hospital /ID# 240786Recruiting
National Hospital Organization Mito Medical Center /ID# 241709Recruiting
Ibaraki Prefectural Central Hospital /ID# 246145Recruiting
Iwate Medical University Hospital /ID# 239027Recruiting
Kitasato University Hospital /ID# 239958Recruiting
Yokohama City University Medical Center /ID# 246554Recruiting
Kanagawa Cardiovascular and Respiratory Center /ID# 239052Recruiting
Kumamoto University Hospital /ID# 241039Recruiting
National Hospital Organization Mie Chuo Medical Center /ID# 246659Recruiting
Miyagi Cancer Center /ID# 234198Recruiting
Sendai Kousei Hospital /ID# 253350Recruiting
University of Miyazaki Hospital /ID# 242161Recruiting
Nagaoka Red Cross Hospital /ID# 240714Recruiting
Kurashiki Central Hospital /ID# 239344Recruiting
Osaka Habikino Medical Center /ID# 239989Recruiting
Kansai Medical University Hospital /ID# 233476Recruiting
Osaka Metropolitan University Hospital /ID# 238895Recruiting
Kindai University Hospital /ID# 239085Recruiting
Tochigi Cancer Center /ID# 240020Recruiting
Juntendo University Hospital /ID# 239932Recruiting
National Hospital Organization Tokyo Medical Center /ID# 246581Recruiting
NTT Medical Center Tokyo /ID# 241067Recruiting
Keio University Hospital /ID# 239506Recruiting
Toyama University Hospital /ID# 241660Recruiting
Wakayama Medical University Hospital /ID# 234004Recruiting
Yamagata University Hospital /ID# 240815
Fujieda Municipal General Hospital /ID# 255155Recruiting
CHA University Bundang Medical Center /ID# 233318Recruiting
Ajou University Hospital /ID# 233319Recruiting
Gyeongsang National University Hospital /ID# 234244Recruiting
Kangbuk Samsung Hospital /ID# 233711Recruiting
SMG-SNU Boramae Medical Center /ID# 233710Recruiting
Clinical Research & Oncology Oaxaca /ID# 231883Recruiting
HagaZiekenhuis /ID# 243693Recruiting
Ziekenhuis St. Jansdal /ID# 251932Recruiting
Maastricht Universitair Medisch Centrum /ID# 233932Recruiting
Isala /ID# 238846Recruiting
Instytut Centrum Zdrowia Matki Polki /ID# 239024Recruiting
MRUK-MED I Sp. z o.o. /ID# 239363Recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025Recruiting
Fundação Champalimaud /ID# 241925Recruiting
Hospital CUF Porto /ID# 241570Recruiting
Oncocenter - Oncologie Clinica Srl /Id# 239103Recruiting
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826Recruiting
Sc Oncolab Srl /Id# 239105Recruiting
SC RTC Radiology Therapeutic Center SRL /ID# 240744Recruiting
S.C. Sigmedical Services SRL /ID# 239108Recruiting
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084Recruiting
Wits Clinical Research Site /ID# 230841Recruiting
Sandton Oncology Medical Group PTY Ltd /ID# 230843
UOMi Cancer Center - Clinica Tres Torres /ID# 240584Recruiting
Hospital Universitario de Jaen /ID# 240588Recruiting
Hospital Universitario 12 de Octubre /ID# 240176Recruiting
Hospital Clinico Universitario de Valencia /ID# 240378Recruiting
Sahlgrenska University Hospital /ID# 229943Recruiting
Karolinska University Hospital /ID# 229853Recruiting
Changhua Christian Hospital /ID# 238394Recruiting
National Taiwan University Hospital - Hsinchu branch /ID# 238393Recruiting
Hualien Tzu Chi Hospital /ID# 238398Recruiting
E-DA Cancer Hospital /ID# 239718Recruiting
Chung Shan Medical University Hospital /ID# 238444Recruiting
National Taiwan University Hospital /ID# 238378Recruiting
MacKay Memorial Hospital /ID# 238392Recruiting
Taipei Medical University Hospital /ID# 238380Recruiting
Memorial Ankara Hastanesi /ID# 234212Recruiting
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209Recruiting
Adana Acibadem Hospital /ID# 234208Recruiting
Ankara City Hospital /ID# 234210Recruiting
Inonu Universitesi Turgut Ozal /ID# 234038Recruiting
Uludag University Medical Faculty /ID# 234205Recruiting
Dicle Universitesi Tip /ID# 234036Recruiting
Bagcilar Medipol Mega Universite Hastanesi /ID# 234211Recruiting
Ege University Medical Faculty /ID# 234039Recruiting
Nottingham University Hospitals NHS Trust /ID# 254707Recruiting
The Christie Hospital /ID# 243422Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telisotuzumab Vedotin

Docetaxel

Arm Description

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) per Independent Central Review (ICR)

PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per ICR or death from any cause.

Overall Survival (OS)

OS is defined as the time from randomization to the event of death from any cause.

Secondary Outcome Measures

Objective Response Rate (ORR), per ICR.

ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1

Duration of Response (DoR), per ICR

DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.

PFS per Investigator Assessment

PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.

Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)

The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.

Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).

The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.

Full Information

NCT ID

NCT04928846

First Posted

June 14, 2021

Last Updated

October 23, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT04928846

Brief Title

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Official Title

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2022 (Actual)

Primary Completion Date

June 7, 2025 (Anticipated)

Study Completion Date

March 21, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

c-Met Overexpressing Non-Small Cell Lung Cancer, c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Docetaxel, Cancer, Non Small Cell Lung Cancer, NSCLC, TeliMET NSCLC-01, Teliso-V

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

698 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telisotuzumab Vedotin

Arm Type

Experimental

Arm Description

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Arm Title

Docetaxel

Arm Type

Active Comparator

Arm Description

Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.

Intervention Type

Biological

Intervention Name(s)

Telisotuzumab Vedotin

Other Intervention Name(s)

ABBV-399

Intervention Description

Intravenous (IV) Infusion

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

IV Infusion

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) per Independent Central Review (ICR)

Description

Time Frame

Up to approximately 39 months

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization to the event of death from any cause.

Time Frame

Up to approximately 39 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR), per ICR.

Description

ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1

Time Frame