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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Duration of response by IA
Duration of response by IRC
Overall response rate by IA
+10 moreSide effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Paraesthesia
20%
Insomnia
20%
Alopecia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Depression
9%
Dysphonia
9%
Pyrexia
8%
Dry skin
8%
Anxiety
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Rhinorrhoea
6%
Oropharyngeal pain
6%
Dehydration
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Anal fissure
1%
Clostridium difficile colitis
1%
Infected dermal cyst
1%
Intestinal perforation
1%
Colonic obstruction
1%
Inguinal hernia
1%
Muscle abscess
1%
Ileus
1%
Gastroenteritis viral
1%
Colitis
1%
Infective exacerbation of chronic obstructive airways disease
1%
Gastrointestinal perforation
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B
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 4
~2680
Lurbinectedin
2022
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
PharmaMarLead Sponsor
90 Previous Clinical Trials
10,832 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other ways in which Irinotecan has been studied?
"663 clinical trials have been completed for irinotecan since 2002, when it was first studied at Mayo Clinic. As of now, there are 336 active studies being conducted, a large portion of which are based in Toronto and North carolina."
Answered by AI
Are there vacancies in this trial for new participants?
"Yes, this clinical trial is still looking for participants. The most recent update on clinicaltrials.gov was on November 3rd, 2022 and the trial was originally posted on July 22nd of the same year."
Answered by AI
What has been the most common side effect in people who have taken Irinotecan?
"There is some clinical evidence to support the efficacy of irinotecan, as well as numerous rounds of data collected to support its safety. Consequently, we have rated irinotecan as a 3 on our safety scale."
Answered by AI
At how many different hospitals is this clinical trial taking place?
"University Health Network - Princess Margaret Hospital in Toronto, North carolina, FirstHealth Outpatient Cancer Center in Pinehurst, Illinois, and McGill University Health Centre (MUHC) in Montréal, Massachusetts are all locations where this study is recruiting patients. In addition, there are 6 other sites."
Answered by AI
What conditions does Irinotecan treat most often?
"Most often, irinotecan is used to treat leukemia, myelocytic, and acute conditions. However, it has also been known to be effective in treating colorectal carcinoma, ovarian cancer, and sarcoma."
Answered by AI
Who else is applying?
What site did they apply to?
Florida Cancer Specialists - South
What portion of applicants met pre-screening criteria?
Did not meet criteria
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