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Topoisomerase I inhibitors
Lurbinectedin +/- Irinotecan for Small Cell Lung Cancer
Phase 3
Recruiting
Research Sponsored by PharmaMar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to the date of death or last contact, up to 39 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing two different experimental treatments for small cell lung cancer that has returned after one other treatment. One experimental treatment is a single drug, and the other experimental treatment is a combination of two drugs. The trial will compare how well the experimental treatments work to a standard treatment.
Who is the study for?
Adults with small-cell lung cancer who've had one prior platinum-based chemotherapy can join this trial. They must have good organ function, no recent serious heart issues or uncontrolled infections, and cannot be pregnant or breastfeeding. Participants need to agree to use effective contraception and should not have been treated with certain drugs like lurbinectedin before.
What is being tested?
The LAGOON trial is testing the effectiveness of Lurbinectedin alone (Group A) or combined with Irinotecan (Group B), compared to the standard treatment choice of Topotecan or Irinotecan (Group C). This phase III study randomly assigns patients to these groups in an open-label setting.
What are the potential side effects?
Possible side effects include fatigue, nausea, low blood counts leading to increased infection risk, liver enzyme changes, shortness of breath from lung inflammation, allergic reactions and potential for other drug-specific adverse effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and every six weeks (± one week) until end of treatment, up to 39 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and every six weeks (± one week) until end of treatment, up to 39 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival
Secondary study objectives
Duration of response by IA
Duration of response by IRC
Overall response rate by IA
+10 moreSide effects data
From 2020 Phase 2 & 3 trial • 483 Patients • NCT0309803066%
Anaemia
51%
Neutropenia
28%
Asthenia
26%
Decreased appetite
26%
Neutrophil count decreased
25%
Nausea
25%
Thrombocytopenia
20%
Platelet count decreased
18%
Fatigue
16%
White blood cell count decreased
15%
Diarrhoea
15%
Pyrexia
15%
Constipation
15%
Dyspnoea
14%
Leukopenia
11%
Alopecia
10%
Abdominal pain
10%
Hyperglycaemia
10%
Cough
10%
Pneumonia
9%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
7%
Vomiting
7%
Back pain
7%
Stomatitis
7%
Anemia
7%
Dizziness
6%
Lymphocyte count decreased
6%
Abdominal pain upper
6%
Blood alkaline phosphatase increased
6%
Blood lactate dehydrogenase increased
6%
Non-cardiac chest pain
6%
Hypotension
5%
Hypokalaemia
5%
Hypomagnesaemia
5%
Headache
5%
Arthralgia
5%
Febrile neutropenia
3%
Productive cough
3%
Pain in extremity
3%
Bronchitis
3%
Musculoskeletal chest pain
3%
Muscular weakness
3%
Hypertension
2%
Small cell lung cancer
2%
Chronic obstructive pulmonary disease
2%
Confusional state
2%
Neck pain
2%
Myalgia
2%
Anxiety
2%
Upper respiratory tract infection
2%
Musculoskeletal pain
2%
Pleural effusion
2%
Haemoglobin decreased
2%
Hyponatraemia
2%
Pulmonary embolism
1%
Hypocalcaemia
1%
Dysphonia
1%
Hypertriglyceridaemia
1%
Respiratory tract infection
1%
Diarrhea
1%
Rash
1%
Klebsiella sepsis
1%
Blood creatinine increased
1%
Dyskinesia
1%
Hypoxia
1%
Dehydration
1%
Acute coronary syndrome
1%
Cardiac failure
1%
Febrile bone marrow aplasia
1%
Ejection fraction decreased
1%
Epistaxis
1%
Pyelonephritis
1%
Atrial flutter
1%
Dry mouth
1%
Acute kidney injury
1%
Death
1%
Acute myocardial infarction
1%
Supraventricular tachycardia
1%
Gastrooesophageal reflux disease
1%
Neutropenic colitis
1%
Herpes zoster
1%
Pain
1%
Hypercholesterolaemia
1%
Leukocytosis
1%
Troponin I increased
1%
Chest pain
1%
Pleuritic pain
1%
Malignant pleural effusion
1%
Metastases to central nervous system
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Topotecan
Part 2: Dinutuximab + Irinotecan
Part 1: Dinutuximab + Irinotecan
Part 2: Irinotecan
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lurbinectedin plus IrinotecanExperimental Treatment2 Interventions
Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle):
* Irinotecan (Day 1 and Day 8)
* Lurbinectedin (Day 1)
Group II: LurbinectedinExperimental Treatment1 Intervention
Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle)
Group III: Control armActive Control2 Interventions
Best Investigator's choice prior to randomization between:
* Irinotecan on Day 1 q3wk
* Topotecan on Days 1-5 q3wk
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 3
~2590
Lurbinectedin
2022
Completed Phase 3
~780
Find a Location
Who is running the clinical trial?
PharmaMarLead Sponsor
91 Previous Clinical Trials
10,979 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious heart issues like a heart attack or unstable angina in the past year.I have a heart rhythm problem that needs treatment.I have a chronic liver condition that needs treatment and haven't taken hepatitis antiviral drugs in the last 6 months.I have needed oxygen in the last two weeks, possibly due to lung disease.I have or might have a serious fungal infection needing treatment in the last 3 months.I am not pregnant, breastfeeding, and I use effective birth control.I do not have active or untreated brain metastases or carcinomatous meningitis.I have not received a live vaccine within the last 30 days.My cancer is confirmed as small cell lung cancer.I can take care of myself but might not be able to do heavy physical work.I was offered and either completed or refused local therapy for my limited-stage disease before joining the trial.I had another cancer treated over 3 years ago and have been in remission since, except for certain skin, cervical, or bladder cancers.More than 35% of my bone marrow has received radiation therapy.I need radiation therapy soon for painful bone cancer or to prevent spinal cord issues.I have a liver condition due to alcohol or cirrhosis with a moderate to severe score.I have fluid buildup in my chest or heart area that needs quick treatment.My blood, kidney, liver, and metabolic functions are within normal ranges.I have had a bone marrow or stem cell transplant.I am not allergic to the study drugs or their ingredients.I do not have any ongoing infections, non-healing wounds, or fractures.I am HIV positive.It's been over 30 days since my last chemotherapy before my cancer progressed.My kidney function, measured by creatinine clearance, is adequate.I have been diagnosed with Gilbert's disease.I've had one round of chemotherapy that included platinum and may have had treatments targeting PD-1 or PD-L1.I have had chronic inflammation in my colon or liver, or past blockages in my intestines.I completed brain radiation at least 2 weeks ago and any other radiation.I am not able to have children or will use effective birth control during and after treatment.I am 18 years old or older.It's been over 3 weeks since my last cancer treatment and I've mostly recovered from side effects.I have previously been treated with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors.I have not had platinum-based chemotherapy or have had more than one chemotherapy regimen.My brain metastases are stable, I've had no symptoms, and I haven't needed steroids for 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Lurbinectedin plus Irinotecan
- Group 2: Control arm
- Group 3: Lurbinectedin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.