Participant flow

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma · Source last updated 2026-02-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.

   id

   FG000

   title

   Lenvatinib 18 mg Plus Everolimus 5 mg

2. description

   Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.

   id

   FG001

   title

   Lenvatinib 20 mg Plus Pembrolizumab 200 mg

3. description

   Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.

   id

   FG002

   title

   Sunitinib 50 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         123

      2. group Id

         FG001

         num Subjects

         97

      3. group Id

         FG002

         num Subjects

         174

      type

      Radiological Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         22

      type

      Clinical Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         63

      2. group Id

         FG001

         num Subjects

         60

      3. group Id

         FG002

         num Subjects

         41

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         23

      type

      Subject Choice

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         9

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         3

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         112

      2. group Id

         FG001

         num Subjects

         142

      3. group Id

         FG002

         num Subjects

         67

      type

      Treatment Ongoing at Cutoff Date

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         17

      type

      Randomized but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         357

      2. group Id

         FG001

         num Subjects

         355

      3. group Id

         FG002

         num Subjects

         357

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         355

      2. group Id

         FG001

         num Subjects

         352

      3. group Id

         FG002

         num Subjects

         340

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         357

      2. group Id

         FG001

         num Subjects

         355

      3. group Id

         FG002

         num Subjects

         357

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 1417 participants were screened, of which, 1069 were randomized. Of the 1069 randomized, 1047 participants were treated in the study.

recruitment Details

Participants took part in the study at 181 investigative sites in Austria, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland, the United States of America, Australia, Czechia, Israel, Japan, Korea, Russian Federation, from 13 October 2016 to 28 August 2020 (date of data cutoff for the primary analysis of PFS and second interim analysis of Overall Survival).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice