NSCLC (Non-small Cell Lung Carcinoma)Phase 3LEDANGNCT07050043
Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC
A Phase 3 study testing Nivolumab 40mg and Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel in people with NSCLC (Non-small Cell Lung Carcinoma) and First Line Therapy, run by Dr Arvindran A/L Alaga at 1 site in Malaysia.
Trial summary
This is a multicenter, two-arm randomized, parallel group design trial to evaluate superiority and safety of low dose Nivolumab (40mg) combined with standard chemotherapy versus standard chemotherapy alone in patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Carcinoma), First Line Therapy, Locally Advanced/Metastatic NSCLC
- What is being tested?
- Nivolumab 40mg and Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 May 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- Histologically confirmed, treatment naïve, locally advanced, or metastatic (stage IIIB - IV (per AJCC version 8), squamous or non-squamous NSCLC with documented PD-L1 expression and is not eligible for definitive chemo-radiation curative therapy and surgery.
- Patients must be treatment naïve with respect to locally advanced or metastatic disease. Patients who received prior treatment with curative intent for early stage disease and develop recurrent advanced/ metastatic disease must have completed treatment at least 6 months prior to first dose of IP.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- At least 1 measurable lesion by RECIST 1.1 in solid tumors criteria.
- Participants must have adequate organ function including the following laboratory values at the screening visit as per Table 2:
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- If a participant has brain or meningeal metastases, the participant must meet the following criteria:
- Metastatic brain lesions do not require immediate intervention. Note: Asymptomatic, treated and stable as well as not requiring steroids for at least 2 weeks prior to start study Treatment.
- Carcinomatous meningitis is excluded regardless of clinical stability.
- A male participant must agree to use a contraception starting with the first dose of study treatment through the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP), OR,
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment.
- Can provide evaluable archival tumor tissue sample or willing to provide tissue from newly obtained core or excisional biopsy or fine needle aspirate (FNA) cell block form of tumor lesion not previously irradiated. Note: Formalin fixed, paraffin embedded (FFPE) tissue blocks or slides allowed.
Who cannot join
- Presence of EGFR, ALK , ROS1 mutation(s).
- Patients with locally advanced disease who can receive other potentially curative therapies, such as patients who can afford to pay for or can otherwise access clinically approved doses of immunotherapy.
- Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
- Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
- Underlying medical conditions that, in the Investigator's or Sponsor PI's opinion, will make the administration of IP(s) hazardous, including but not limited to interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of NSCLC is not disqualifying), or active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP.
- Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded).
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- Active hepatitis B and C infection or human immunodeficiency virus antibody (HIV-1 and/or HIV-2) positive at screening.
- Known hypersensitivity to recombinant proteins, or any excipient contained in the IP formulations.
- Known history of autoimmune disease currently on immunosuppressive medications.
- Known history of second malignancy within two years prior enrolment.
- Prognosis of three months or less.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation. If the urine test positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Dr. Avindran A/L Alaga, +6047407395, arvindran_82@yahoo.com
Dr. Avindran A/L Alaga
About this study
Official title: A Phase III RCT Comparing Low Dose Immunotherapy (Nivolumab) Combined With Standard Chemotherapy vs Standard Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic NSCLC
This is a multicenter, two-arm randomized, parallel group design trial to evaluate superiority and safety of low dose Nivolumab (40mg) combined with standard chemotherapy versus standard chemotherapy alone in patients with non-small cell lung cancer.
Read the detailed description
Eligible subjects who satisfy the inclusion and exclusion criteria will be randomized 2:1 into 2 arms (Low dose nivolumab arm consisting of six-weekly 40mg Nivolumab plus 4-6* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice, versus standard chemotherapy alone, consisting 4-6* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice.
- Conditions
- NSCLC (Non-small Cell Lung Carcinoma), First Line Therapy, Locally Advanced/Metastatic NSCLC
- Being tested
- Nivolumab 40mg, Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 40mgDrug
Also called Opdivo
Nivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer.
Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, DocetaxelDrug
Also called CDDP, Paraplatin, Taxotere, CBDCA
Cisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Standard Chemotherapy | Experimental | Patient will be receiving of low dose Nivolumab (40mg) combined with standard chemotherapy Receives: Drug: Nivolumab 40mg; Drug: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel |
| Standard Chemotherapy | Active comparator | Patient will be receiving standard chemotherapy alone. Receives: Drug: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Determine the PFS of six-weekly Nivolumab 40mg combined with standard chemotherapy versus standard chemotherapy alone in NSCLC
Measured: From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months
Secondary outcomes (9)
Overall Survival (OS)
Evaluate the OS of six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC
Measured: From the date of treatment commencement to the date death from any cause or the date of the last follow-up before final analysis (whichever comes first) - up to 36 months
Patient-Reported Outcome Measure (PROM)
Evaluate PROM for six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC. For each tool, domain scores and individual scores will be calculated using the scoring or developer's guidelines
Measured: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
PROM using EORTC QLQ-C30
A 30-question survey that looks at overall quality of life in cancer patients. It measures five functional dimensions (physical, role, emotional, cognitive, and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact) and global health and quality of life
Measured: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
PROM using EQ-5D-5L
A 6-question tool to assess general health and well-being through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
PROM using NSCLC-SAQ
A 7-question survey that focuses on lung cancer symptoms, including cough, dyspnea, pain, fatigue, and appetite
Measured: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants experiencing at least one TEAE, as defined by CTCAE v5.0
Measured: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Serious Adverse Events (SAEs)
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants experiencing at least one SAE, as defined by CTCAE v5.0
Measured: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Treatment-Related Discontinuations
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants who discontinue treatment due to adverse events, as defined by CTCAE v5.0
Measured: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Treatment-Related Deaths
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants who die due to adverse events, as defined by CTCAE v5.0
Measured: From first dose to last dose of treatment plus follow-up - up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start19 May 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Carcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Arvindran A/L Alaga
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr Arvindran A/L Alaga, Hospital Sultanah Bahiyah
- Investigators
- Dr. Arvindran A/L Alaga, Principal investigator, Hospital Sultanah Bahiyah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050043
- Sponsor's protocol ID
- IIT-LEDANG2023001
- Other IDs
- NIH/800-3/2/2 Jilid 18 (38)
- Acronym
- LEDANG
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III RCT Comparing Low Dose Immunotherapy (Nivolumab) Combined With Standard Chemotherapy vs Standard Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT07050043
- Acronym / sponsor ID
- LEDANG / IIT-LEDANG2023001
- Conditions
- NSCLC (Non-small Cell Lung Carcinoma), First Line Therapy, Locally Advanced/Metastatic NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Dr Arvindran A/L AlagaOther government
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, two-arm randomized, parallel group design trial to evaluate superiority and safety of low dose Nivolumab (40mg) combined with standard chemotherapy versus standard chemotherapy alone in patients with non-small cell lung cancer.
Detailed description
Eligible subjects who satisfy the inclusion and exclusion criteria will be randomized 2:1 into 2 arms (Low dose nivolumab arm consisting of six-weekly 40mg Nivolumab plus 4-6* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice, versus standard chemotherapy alone, consisting 4-6* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Standard Chemotherapy | Experimental | Drug: Nivolumab 40mg, Drug: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, DocetaxelPatient will be receiving of low dose Nivolumab (40mg) combined with standard chemotherapy |
| Standard Chemotherapy | Active comparator | Drug: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, DocetaxelPatient will be receiving standard chemotherapy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- Histologically confirmed, treatment naïve, locally advanced, or metastatic (stage IIIB - IV (per AJCC version 8), squamous or non-squamous NSCLC with documented PD-L1 expression and is not eligible for definitive chemo-radiation curative therapy and surgery.
- Patients must be treatment naïve with respect to locally advanced or metastatic disease. Patients who received prior treatment with curative intent for early stage disease and develop recurrent advanced/ metastatic disease must have completed treatment at least 6 months prior to first dose of IP.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- At least 1 measurable lesion by RECIST 1.1 in solid tumors criteria.
Key exclusion criteria (12 listed)
- Presence of EGFR, ALK , ROS1 mutation(s).
- Patients with locally advanced disease who can receive other potentially curative therapies, such as patients who can afford to pay for or can otherwise access clinically approved doses of immunotherapy.
- Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
- Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
- Underlying medical conditions that, in the Investigator's or Sponsor PI's opinion, will make the administration of IP(s) hazardous, including but not limited to interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of NSCLC is not disqualifying), or active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab 40mgAlso: OpdivoNivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer. | Drug | Nivolumab + Standard Chemotherapy |
| Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, DocetaxelAlso: CDDP, Paraplatin, Taxotere, CBDCACisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer. | Drug | Nivolumab + Standard Chemotherapy, Standard Chemotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months
Determine the PFS of six-weekly Nivolumab 40mg combined with standard chemotherapy versus standard chemotherapy alone in NSCLC
9 secondary outcomes
Overall Survival (OS)
Time frame: From the date of treatment commencement to the date death from any cause or the date of the last follow-up before final analysis (whichever comes first) - up to 36 months
Patient-Reported Outcome Measure (PROM)
Time frame: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
PROM using EORTC QLQ-C30
Time frame: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
PROM using EQ-5D-5L
Time frame: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
PROM using NSCLC-SAQ
Time frame: From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Serious Adverse Events (SAEs)
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Treatment-Related Discontinuations
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Treatment-Related Deaths
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Arvindran A/L Alaga principal investigator
Hospital Sultanah Bahiyah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab 40mg and Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel in people with NSCLC (Non-small Cell Lung Carcinoma) and First Line Therapy, run by Dr Arvindran A/L Alaga at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Arvindran A/L Alaga (+6047407395, arvindran_82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.