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Alkylating agents

Sacituzumab Govitecan Combo for Lung Cancer (EVOKE-02 Trial)

Phase 2

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

Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment

Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator No prior systemic treatment for metastatic NSCLC

Must not have

Mixed SCLC and NSCLC histology

Active second malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for advanced or metastatic non-small-cell lung cancer (NSCLC) that has not responded to other treatments. The primary objectives are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of the new therapy.

Who is the study for?

This trial is for adults with advanced or metastatic non-small-cell lung cancer (NSCLC) who haven't had systemic treatment for it. They should have a good performance status, meaning they can carry out daily activities with little or no assistance. Their blood counts and liver function need to be within certain ranges, and their disease must be measurable on scans.

What is being tested?

Researchers are testing the drug sacituzumab govitecan-hziy (SG), alone and in combination with pembrolizumab and either carboplatin or cisplatin. The study aims to find effective dosing regimens for patients with NSCLC that has spread beyond its original site.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, lowered blood cell counts which can increase infection risk, potential liver issues, fatigue, nausea, and other symptoms related to how these drugs affect the body's normal cells as well as cancer cells.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at stage IV.

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My cancer can be measured on scans and I haven't had systemic treatment for advanced lung cancer.

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I am fully active or can carry out light work.

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My lung cancer is at stage IV.

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My cancer can be measured on scans according to specific criteria.

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I haven't had any systemic treatment for my advanced lung cancer.

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I am fully active or can carry out light work.

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My lung cancer is at stage IV.

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My cancer can be measured on scans.

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I haven't had any systemic treatment for my advanced lung cancer.

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

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I have another type of cancer that is currently active.

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My NSCLC can be treated with local therapy only.

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I have an immune system disorder or am on long-term steroids.

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I have been treated for an autoimmune disease in the last 2 years.

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I have received an organ or tissue transplant from another person.

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I have a severe allergy to SG, pembrolizumab, carboplatin, or cisplatin.

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I have undergone radiation therapy for my lung.

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I haven't had any cancer treatment in the last 6 months.

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I have severe lung problems due to other lung diseases.

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I have active cancer spread to my brain or spinal cord.

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I have a history of heart disease.

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I have an ongoing inflammatory bowel condition.

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I am currently taking antibiotics for a serious infection.

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I have an ongoing or chronic hepatitis B infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)Experimental Treatment2 Interventions

Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.

Group II: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)Experimental Treatment3 Interventions

Participants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m\^2 on Day 1 of a 21-day cycle.

Group III: SG + Pembrolizumab + Cisplatin (Cohort E)Experimental Treatment3 Interventions

Participants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m\^2 on Day 1 of a 21-day cycle.

Group IV: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)Experimental Treatment4 Interventions

Participants assigned to Cohort D according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.

Group V: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)Experimental Treatment4 Interventions

Participants assigned to Cohort C according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.

Group VI: SG + Pembrolizumab + Carboplatin Safety Run-inExperimental Treatment3 Interventions

Participants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle.

Group VII: SG + Pembrolizumab (Cohort B)Experimental Treatment2 Interventions

Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan-hziy (SG)

2012

Completed Phase 2

~520

Pembrolizumab

2017

Completed Phase 3

~3150