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At a glance
- Treatment
- Lurbinectedin; Zepzelca
- Used in selected settings
- Selected adults with extensive-stage small-cell lung cancer, particularly maintenance with atezolizumab
- How it is given
- An infusion into a vein over about 1 hour. The team may recommend a central line or port because leakage into surrounding tissue can cause serious damage. If atezolizumab is being given on the same day, it is given first.
- Before you start
- Save your 24-hour oncology number. Have a thermometer and written treatment calendar available.
Bring any new symptoms to the team’s attention promptly. With atezolizumab, immune-system inflammation can affect the lungs, bowel, liver, glands or other organs and may occur even after treatment stops. Do not assume every symptom is ordinary chemotherapy toxicity.
What this treatment is and how it works
Lurbinectedin is a chemotherapy medicine. It attaches to DNA (the genetic instructions inside cells) and interferes with how cells use those instructions. This damages cancer cells and can stop them growing. It is a different type of treatment from atezolizumab, which is immunotherapy.
When it may be used
Current US and European product information describes lurbinectedin with atezolizumab as maintenance treatment for adults with extensive-stage small-cell lung cancer whose cancer has not progressed after initial atezolizumab, carboplatin and etoposide. Maintenance aims to keep the cancer controlled after that initial phase.
Lurbinectedin has also been used alone after platinum chemotherapy. However, the US accelerated approval for that separate use was withdrawn on 30 September 2026. The maintenance-combination indication remains. Earlier websites or leaflets may still show the former US indication. Approvals and access differ between countries; your oncologist must confirm the current local position and reason for treatment.
This is an individual-drug sheet, but it does not imply that lurbinectedin should routinely be given alone. When it is paired with atezolizumab, you also need the immunotherapy information and alert card.
Licences and access differ by country and product. This sheet does not establish Indian regulatory approval or availability. Your oncologist will explain the locally appropriate treatment.
Before treatment
Before starting, tell the team about previous cancer treatment, allergies, infection symptoms, heart, lung, kidney or liver disease, hearing or nerve problems, diabetes and all medicines you take. Discuss pregnancy, contraception and fertility. Ask for a written treatment calendar, supportive-medicine instructions and a 24-hour oncology contact number. Baseline blood tests usually include a full blood count and kidney and liver function; additional tests depend on the medicine and your health. Before chemotherapy that reaches the whole body, the team should check for current or past hepatitis B infection. If a test is positive, extra monitoring or antiviral treatment may be needed to prevent the virus becoming active again. The team will coordinate testing and treatment; do not delay urgent cancer treatment yourself.
How treatment is given and the schedule
An infusion into a vein over about 1 hour. The team may recommend a central line or port because leakage into surrounding tissue can cause serious damage. If atezolizumab is being given on the same day, it is given first.
A usual cycle is every 3 weeks. Treatment continues while it is helping and side effects remain acceptable. The team may delay or reduce lurbinectedin, or stop one or both drugs, according to symptoms and test results.
Anti-sickness medicines are given before treatment. Preventive granulocyte colony-stimulating factor (G-CSF) injections, which help the body make infection-fighting white cells, are part of the labelled maintenance-combination approach to lower the risk of fever with low white cells. Ask for the exact injection dates and whom to call if a dose is missed; G-CSF does not remove the need to report fever.
The dose is calculated for your treatment and health. Do not change the dose or treatment dates yourself. The team will provide a revised calendar if treatment needs to be delayed, reduced or stopped.
Tests and monitoring during treatment
- A full blood count before every cycle checks infection-fighting cells, red cells and platelets. Low results may require postponement, dose changes, transfusions or additional support.
- Liver tests before starting and regularly during treatment, with kidney function and blood salts as appropriate. The muscle enzyme creatine phosphokinase (CPK) is checked before treatment and periodically, or promptly if symptoms suggest muscle injury.
- During combination treatment, thyroid and other tests and symptom checks follow the atezolizumab plan as well. The team reviews breathing, general fitness, the infusion site and scans showing cancer response. Pregnancy testing is arranged where relevant.
Tell the team about symptoms since the previous dose, including problems that have already settled. A normal earlier test does not make new symptoms safe to ignore.
Side effects: what to expect
The table groups frequently reported problems. The current European frequency data are mainly from lurbinectedin with atezolizumab, so they cannot establish the frequency caused by lurbinectedin alone. Routine blood-test changes can be more frequent than symptoms. Serious does not mean rare.
You are unlikely to have every effect listed, and this is not an exhaustive list. Report new symptoms even if they are not mentioned here.
Common or more frequent side effects
| Possible effect | What you can do | When to contact the team |
|---|---|---|
| Low blood counts | White cells fight infection, red cells carry oxygen and platelets help clotting. Treatment can lower one or more of these. Wash hands, avoid close contact with people who are unwell and keep blood-test appointments. | Call immediately for fever, shaking chills or feeling suddenly unwell. Report unusual bruising, bleeding, marked tiredness or increasing breathlessness. Do not wait for a blood-test result before seeking help. |
| Feeling or being sick | Take preventive anti-sickness medicines at the prescribed times. Try small meals and frequent small drinks; avoid strong food smells if they worsen nausea. | Contact the team the same day if medicines are not controlling symptoms. Seek urgent advice if you cannot keep fluids down, feel faint or pass much less urine. |
| Tiredness and reduced stamina | Balance rest with short periods of gentle activity. Prioritise tasks and accept help with shopping, meals or transport. Tell the team about poor sleep or pain. | Report fatigue that prevents basic activities or is worsening. Sudden breathlessness, chest pain, fainting or confusion needs urgent assessment. |
| Reduced appetite or changes in eating | Try smaller, frequent meals with protein and energy-rich foods you tolerate. Ask for a dietitian if your weight or intake is falling. | Report ongoing weight loss or difficulty eating. Inability to drink or signs of dehydration needs same-day urgent advice. |
| Loose or more frequent stools (diarrhoea) | Record how often you pass stools and follow the team’s fluid and anti-diarrhoea plan. Use small, regular drinks unless you have a fluid restriction. | Report new or worsening diarrhoea promptly. Fever, blood, severe abdominal pain, dizziness or difficulty drinking needs urgent assessment. |
| Constipation | Keep a bowel record. Gentle movement, usual fluids and a prescribed laxative can help. Ask before using suppositories or enemas when blood counts may be low. | Contact the team for worsening constipation. A swollen or painful abdomen, vomiting or inability to pass wind needs urgent assessment; do not simply add laxatives. |
| Changes in liver blood tests | Attend blood tests even if you feel well. Check medicines and supplements with the pharmacist. | Report yellow eyes or skin, dark urine, severe upper-abdominal pain or confusion urgently. The team may need to pause or change treatment. |
| Muscle or joint aches | Use only pain relief agreed with your team and balance gentle activity with rest. | Urgently report severe muscle pain or weakness, especially with dark urine or reduced urine. |
| Breathlessness or cough | Report a change from your normal breathing promptly. | New or worsening breathlessness can be infection, the cancer or immune-related lung inflammation. Severe breathing difficulty requires emergency assessment. |
Other reported side effects (frequency varies)
Taste changes, headache, mouth soreness, rash, itching, tingling or numbness and inflammation around a vein can occur. Low thyroid function may occur in the combination setting and needs assessment under the immunotherapy plan. Muscle breakdown, tissue injury after leakage and tumour lysis have been reported, but reliable numerical risks are not available for every event or setting; they are not assigned a false “rare” percentage here.
Important serious side effects, including rare effects
Serious effects can be common, uncommon, rare or have an uncertain frequency. The following advice explains when to seek help; it does not label all serious effects as rare.
Severe infection or bleeding
Lurbinectedin can markedly lower blood counts. Call immediately for fever, chills or sudden illness, including while receiving G-CSF. Uncontrolled bleeding, collapse or severe breathing difficulty needs emergency care.
Liver injury
Yellow eyes or skin, dark urine, marked upper-abdominal pain, unusual bruising or severe unexplained tiredness needs urgent advice. When atezolizumab is also used, the team must consider immune-related liver inflammation as well.
Muscle breakdown (rhabdomyolysis)
Severe muscle pain or weakness, dark urine or a major reduction in urine needs urgent assessment. Muscle breakdown can damage the kidneys. A normal earlier CPK result does not exclude a new problem.
Leakage outside the vein
Tell the nurse immediately about pain, burning, swelling or redness around the line or port. Tissue damage can become apparent after the infusion, so report later changes urgently too. Do not apply home remedies or massage the area.
Tumour lysis syndrome
Rapid cancer-cell breakdown can upset blood salts and kidney function. Severe weakness, cramps, palpitations, reduced urine, confusion or a seizure needs urgent assessment. The team determines whether prevention or additional tests are needed.
Immune-related effects when used with atezolizumab
Call promptly for new diarrhoea, a persistent cough, worsening breathlessness, severe rash, jaundice, unusual thirst, severe headache or profound unexplained weakness. These may need specific treatment, often steroids, rather than routine symptom medicines alone. Do not start steroids yourself.
Practical advice for this treatment
Keep the chemotherapy calendar and immunotherapy alert card together. Record the dates of G-CSF injections and report troublesome bone pain so relief can be arranged. Do not use leftover anti-sickness medicines without checking: some interact with lurbinectedin. Keep the line site clean and follow the hospital’s dressing instructions.
Medicines, interactions and vaccinations
Give the oncology pharmacist a complete list of prescription medicines, over-the-counter products, vitamins, herbal and Ayurvedic remedies and supplements. Ask before starting anything new. Do not stop prescribed medicines, including anticoagulants or infection-prevention medicines, without a coordinated plan. Live vaccines are generally unsuitable while immunity is suppressed; discuss vaccine type and timing with the team. Non-live vaccines may be offered, although protection can be reduced. Follow any specific stop-and-call instructions for the cancer medicine on this page or in your written treatment plan.
Some medicines strongly alter how lurbinectedin is broken down. The pharmacist should check antifungals, antibiotics, HIV medicines, rifampicin, anti-seizure medicines, certain heart medicines, aprepitant and all supplements. The specialist team should review or avoid medicines that strongly or moderately slow the breakdown of lurbinectedin, and those that strongly speed it up. Avoid grapefruit and Seville oranges and products containing them. Statins also need review because of possible muscle injury. Do not change any prescribed medicine yourself.
Pregnancy, fertility and breastfeeding
Chemotherapy can harm a developing baby and may affect fertility temporarily or permanently. Discuss sperm, egg or embryo storage before treatment when feasible. Tell the team immediately about a suspected pregnancy. Periods stopping does not guarantee infertility.
Current product information advises effective contraception during treatment and for 7 months after the last dose for women who could become pregnant, and 4 months for men with partners who could become pregnant. The European SmPC specifies condoms for men and highly effective contraception for female partners during that period. Do not breastfeed during treatment. The US label specifies at least 2 weeks afterwards for lurbinectedin, but atezolizumab or another medicine may require substantially longer: obtain one written plan covering the whole treatment.
Everyday life
Gentle activity, regular meals and rest can help you cope. Prepare food hygienically and drink according to your individual fluid plan. Avoid smoking; ask whether alcohol is safe with your exact treatment and other medicines. Plan work, travel and driving around symptoms and monitoring visits. Do not drive if dizzy, sleepy, weak, visually affected or impaired by neuropathy. You can usually be close to family and friends: chemotherapy does not make you radioactive. Follow the unit’s instructions for handling urine, vomit, laundry and sexual precautions for the period it specifies.
When to contact the oncology team
Contact the oncology team the same day for persistent vomiting or diarrhoea, difficulty drinking, reduced urine, mouth pain affecting eating, new cough, jaundice, a painful or spreading rash, unusual bruising, worsening constipation or new nerve symptoms. Use the more urgent instructions for the particular symptom when given above. If the team cannot be reached and you are unwell, seek urgent medical care.
Write down your hospital’s daytime and out-of-hours numbers before treatment. CTI’s general contact details do not replace the emergency number provided by your treating hospital.
After treatment
Keep the planned blood tests and follow-up appointments after the last dose. Blood counts and immunity may take time to recover, and some effects can start or persist later. Contact the team about symptoms rather than waiting for a routine visit. Keep a treatment summary, including drug names, dates and any serious reactions, for future doctors. Response may be assessed with examination, scans or blood or marrow tests, depending on the cancer.
Words you may hear
- Small-cell lung cancer
- A particular type of lung cancer identified from a tissue sample.
- Extensive-stage
- Small-cell lung cancer that extends beyond the area usually treated as limited-stage disease.
- G-CSF
- Injections that help the body make infection-fighting white blood cells.
Frequently asked questions
Is lurbinectedin immunotherapy?
No. It is chemotherapy. Atezolizumab, which may be given with it, is immunotherapy and has a different set of additional risks.
Why is it given after the first chemotherapy course?
In the maintenance setting, it is added with atezolizumab after initial treatment has controlled the cancer without progression. Your team will explain the expected benefit and alternatives.
Is its old US single-drug approval still current?
No. The separate US post-platinum accelerated approval was withdrawn on 30 September 2026. The maintenance-combination indication remains. Ask the team about the locally applicable indication rather than relying on an old leaflet.
Why do I need G-CSF injections?
They help the bone marrow make infection-fighting white cells and reduce the risk of fever with low counts. You still need urgent advice for fever or sudden illness.
What if my atezolizumab is stopped?
Sometimes lurbinectedin can continue under a specialist plan, depending on why atezolizumab stopped. Do not assume that this is the same as starting single-drug treatment after platinum relapse.
Can I use my usual anti-sickness medicine?
Only after the oncology pharmacist checks it. Some anti-sickness medicines can increase lurbinectedin levels.
Why report diarrhoea promptly?
It could be chemotherapy-related, infection-related or an immune effect from atezolizumab. Those causes need different management.
Does a dose delay mean treatment has failed?
No. A delay may allow blood counts or organ tests to recover. The team judges effectiveness using your symptoms, examination and scans.
Related treatment information
If this medicine is combined with other treatments, ask for each medicine’s information and the complete combination calendar. An individual-drug sheet does not describe every additional risk of a combination.
Sources and further reading
Summary of Product Characteristics
Professional reference resources. The SmPC describes product-specific warnings, interactions, adverse effects and monitoring. US prescribing information is identified separately. Original-brand or direct manufacturer documents are linked where retrieved. The team must also check the product actually supplied in India.
- Zepzelca — EMA product information including SmPC. Accessed 16 October 2026. Current European maintenance-combination indication. Original brand, PharmaMar.
- Zepzelca — manufacturer-hosted US prescribing information. Accessed 16 October 2026. Jazz Pharmaceuticals; revised September 2026. Supersedes the February 2026 US label for indication status.
Other authoritative references
- DailyMed — current Zepzelca US label. Accessed 16 October 2026. Effective 30 September 2026; NLM-hosted current manufacturer label, cross-checked with the direct USPI.
- FDA — Withdrawn cancer accelerated approvals. Accessed 16 October 2026. Records withdrawal of the post-platinum metastatic SCLC indication on 30 September 2026.
- FDA — Lurbinectedin with atezolizumab maintenance approval. Accessed 16 October 2026. 2 October 2025 approval; distinguish from the withdrawn post-platinum indication.
- Paz-Ares et al. — IMforte phase III trial, Lancet 2025. Accessed 16 October 2026. Primary trial abstract via PubMed, PMID 40473449; combination maintenance population.
- BC Cancer — Lurbinectedin interim monograph. Accessed 16 October 2026. Revised 1 June 2022. Used for pharmacology and interaction cross-check only, not current approval status.
- NCI — infection and neutropenia. Accessed 16 October 2026.
- NCI — mouth and throat problems. Accessed 16 October 2026.
- NCI — diarrhoea. Accessed 16 October 2026.
- NCI — fatigue. Accessed 16 October 2026.
- ASCO hepatitis B screening and management opinion. Accessed 16 October 2026. Independent cross-check: Provisional Clinical Opinion: universal three-test screening before or at systemic anticancer therapy; chronic/past infection management.
Editorially approved by Dr (Prof) Vijay Agarwal
Professor and Lead Consultant – Medical Oncology
