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Anti-microtubule agent

Sacituzumab Govitecan for Lung Cancer (EVOKE-01 Trial)

Phase 3

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition)

Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation

Must not have

Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent

Previously received treatment with any of the following: Topoisomerase 1 inhibitors, Trop-2-targeted therapy, Docetaxel as monotherapy or in combination with other agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare overall survival of two treatments for lung cancer patients who have progressed after other treatments.

Who is the study for?

This trial is for adults with advanced or metastatic NSCLC who have already tried a platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. They must have proper liver function, no active second cancers, no brain metastases, and not be pregnant or breastfeeding. Participants need to have recovered from previous treatments' side effects and can't join if they've had certain other cancer therapies.

What is being tested?

The study compares Sacituzumab Govitecan (SG) with Docetaxel in treating NSCLC. Patients will be randomly assigned to receive either SG or Docetaxel to determine which is more effective at controlling the disease.

What are the potential side effects?

Sacituzumab Govitecan may cause nausea, diarrhea, hair loss, fatigue, neutropenia (low white blood cell count), and anemia. Docetaxel can lead to similar side effects including fluid retention and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to be at stage 4.

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My kidneys work well enough to clear at least 30 mL/min of creatinine.

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My cancer got worse after treatment with platinum chemotherapy and anti-PD-1/PD-L1 drugs.

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My blood counts are within the required range without needing transfusions or growth support.

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I have received a TKI treatment for my cancer due to a specific genetic change.

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My liver is functioning well according to recent tests.

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My lung cancer has worsened despite recent treatment.

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I haven't received treatments for recurrent/metastatic cancer due to lack of specific genomic changes.

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My cancer can be measured on a scan.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have significant side effects from a previous treatment.

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I have been treated with specific cancer drugs like Topoisomerase 1 inhibitors, Trop-2 therapy, or Docetaxel.

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I have a current heart condition.

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I am HIV positive with a detectable viral load or take medication that affects SN-38 metabolism.

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I have hepatitis C with a detectable viral load.

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I have severe lung problems or diseases affecting my lungs.

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I have another type of cancer that is currently active.

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I have active brain metastases or cancer in the lining of my brain.

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My NSCLC can be treated with local therapy only.

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My lung cancer is a mix of small-cell and non-small cell types.

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I am currently taking antibiotics for a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1

Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1

Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1

+3 more

Side effects data

From 2020 Phase 1 & 2 trial • 515 Patients • NCT01631552

69%

Nausea

61%

Diarrhoea

57%

Fatigue

44%

Vomiting

44%

Alopecia

42%

Anaemia

40%

Neutropenia

37%

Constipation

35%

Decreased appetite

22%

Abdominal pain

20%

Neutrophil count decreased

20%

Cough

20%

Dyspnoea

18%

Hypokalaemia

18%

Hypomagnesaemia

16%

Pyrexia

16%

White blood cell count decreased

16%

Dehydration

16%

Dizziness

16%

Headache

16%

Rash

16%

Oedema peripheral

15%

Weight decreased

15%

Back pain

14%

Arthralgia

13%

Urinary tract infection

13%

Hypophosphataemia

13%

Pruritus

12%

Upper respiratory tract infection

12%

Insomnia

11%

Hyperglycaemia

11%

Blood alkaline phosphatase increased

Pain in extremity

Alanine aminotransferase increased

Aspartate aminotransferase increased

Lymphocyte count decreased

Hyponatraemia

Rhinorrhoea

Dry skin

Dysgeusia

Chest pain

Chills

Activated partial thromboplastin time prolonged

Hypoalbuminaemia

Neuropathy peripheral

Anxiety

Depression

Muscular weakness

Myalgia

Epistaxis

Nasal congestion

Pain

Asthenia

Dyspepsia

Gastrooesophageal reflux disease

Hypocalcaemia

Hypotension

Abdominal distension

Stomatitis

Haematuria

Febrile neutropenia

Pneumonia

Small intestinal obstruction

Colitis

Atrial fibrillation

Sepsis

Syncope

Mental status changes

Hypoxia

Pleural effusion

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Overall Safety Population

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention

Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Group II: DocetaxelActive Control1 Intervention

Participants will receive docetaxel 75 mg/m\^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan-hziy (SG)

2012

Completed Phase 2

~520

0 / 21Eligibility criteria met