Carcinoma, Small Cell LungPhase 1/2NCT04253145
Study to Assess Safety,Tolerability,Efficacy of PM01183 and Atezolizumab in Patients w/ Advanced Small Cell Lung Cancer.
A Phase 1/2 study testing PM 01183 and Atezolizumab in people with Carcinoma, Small Cell Lung, run by Fundacion Oncosur at 13 sites in Spain.
Trial summary
Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Small Cell Lung
- What is being tested?
- PM 01183 and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 13 sitesSpain
- Study dates
- 13 Dec 2019to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed and dated written informed consent prior to any specific study procedure.
- Age >18 years.
- Histologically or cytologically confirmed diagnosis of extensive or limited SCLC.
- Progression to first-line platinum-based chemotherapy. For phase II part: Progression to first- line platinum-based chemotherapy or first- line platinum- based chemotherapy and immunoterapy (anti PD1/ PDL1). A chemotherapy and/ or immunotherapy- free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤1.
- Measurable disease according to RECIST v.1.1. Note: irradiated lesions may qualify as target if progression has been documented.
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- At least three weeks since last prior anticancer treatment (including radiotherapy) and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.5).
- Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤7 days before inclusion in the study):
- Platelet count ≥100 x 109/L, hemoglobin ≥9.0 g/dL and absolute neutrophil count (ANC) ≥1.5 x 109/L.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x the upper limit of normal (ULN), independently of the presence of liver metastases.
- Alkaline phosphatase (AP) ≤2.5 x ULN.
- Total bilirubin ≤1.5 x ULN or direct bilirubin ≤ULN
- International Normalized Ratio (INR) <1.5 (except if patient is on oral anticoagulation therapy).
- Calculated creatinine clearance (CrCL) ≥30 mL/minute (using Cockcroft and Gault´s formula).
- Creatine phosphokinase (CPK) ≤2.5 x ULN.
- Albumin ≥3.0 g/dL. Albumin infusion to fulfill the inclusion criterion is forbidden.
- Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the ULN, then a free T4 within institutional normal limits is acceptable.
- Evidence of non-childbearing status for women of childbearing potential (WOCBP). Both women and men must agree to use a highly effective contraceptive measure during the trial, for at least five months after last atezolizumab dose, and for at least six weeks (women) or 4 months (men) after last PM01183 dose. Fertile male patients with WOCBP partners must agree to refrain from fathering a child or donating sperm during the trial and up to five months after treatment discontinuation. Acceptable methods of contraception include abstinence, intrauterine device (IUD), oral contraceptive, subdermal implant and/or double barrier.
Who cannot join
- Active or untreated central nervous system (CNS) involvement. Treated CNS metastases have to show radiographic stability (defined as no CNS progression for at least three weeks from post-radiotherapy brain scan to brain scan performed prior study entry), and patients should not have neurologic sign/symptoms secondary to the brain metastases or RT. Any steroid treatment must be completed ≥ 14 days before first dose of study treatment.
- More than one prior chemotherapy-containing line (re-challenge with the same initial regimen is not allowed).
- Patients with radiation therapy (RT) in more than 35% of the bone marrow.
- History of previous bone marrow and/or stem cell transplantation.
- Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
- History of allergy or hypersensitivity to any of the study drugs or their excipients.
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- Prior therapy with PM01183, antibodies against PD-1, PD-L1, PD-L2, CD137, or cytotoxic T lymphocyte associated antigen-4 (CTLA-4). For phase II part: Prior therapy with PM01183, PD-L2, CD137, or cytotoxic T lymphocyte associated antigen-4 (CTLA-4).
- Live vaccines within 30 days prior to start of study treatment and while on treatment.
- History of other prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer. Patients with other prior malignancies and no disease recurrence for 3 years are eligible.
- Concomitant diseases/conditions:
- History or presence of unstable angina, myocardial infarction, congestive heart failure defined as abnormal left ventricular ejection fraction (LVEF) < 50% assessed by multiple-gated acquisition scan (MUGA) or equivalent by ultrasound (US), or clinically significant valvular heart disease within 12 months prior first study dose.
- Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
- Ongoing chronic alcohol consumption, or cirrhosis with Child-Pugh score B or C.
- Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture.
- Diagnose of immunodeficiency or receiving systemic steroids therapy (more than a daily dose of 10 mg of prednisone or equivalent per day) or any other form of immunosuppressive therapy within 14 days prior to the first study dose.
- Active autoimmune disease that required systemic treatment in the past two years (i.e., with disease-modifying agents, corticosteroids and immunosuppressive drugs).
- Patients with vitiligo or resolved childhood asthma/atopy are eligible, as well as patients who require intermittent use of bronchodilators or local steroid injections, patients with hypothyroidism stable on hormone replacement, patients with insulin-treated controlled type 1 diabetes or Sjogren's syndrome.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis or evidence of active pneumonitis on screening chest computed tomography (CT) scans. A history of radiation pneumonitis in radiation field (fibrosis) will be allowed if asymptomatic and not requiring steroids.
- Known history of active tuberculosis (Mycobacterium tuberculosis).
- Ongoing treatment-requiring, non-neoplastic chronic liver disease of any origin. For hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Patients taking hepatitis-related antiviral therapy within 6 months prior to the first study dose will also be excluded.
- Known human immunodeficiency virus (HIV) infection.
- Myopathy or any clinical situation that causes significant and persistent elevation of CPK (>2.5 x ULN in two different determinations performed one week apart).
- Limitation of the patient's ability to comply with the treatment or follow-up procedures.
- Patiens who have previously experienced pericarditis, pericardial effusion and cardiac tamponade) on prior treatment with other immune- stimulatory anticancer agents.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
- Active COVID19 infection determined by PCR (positive result of SARS-CoV-2 virus), not mandatory if fully vaccinated.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites, 13 recruiting
- Recruiting
Hospital Universitario Da Coruña
A Coruña
Mª Rosario García, MA.Rosario.Garcia.Campelo@sergas.es
- Recruiting
Hospital Vall d'Hebron
Barcelona, Catalonia
Alejandro Navarro, anavarro@vhio.net
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Laura Mezquita, LMEZQUITA@clinic.cat
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Margarita Majem, mmajem@santpau.cat
- Recruiting
Hospital 12 de Octubre
Madrid
Santiago Ponce, sponce@h12o.es
- Recruiting
Hospital Universitario La Paz
Madrid
Javier de Castro, javier.decastro@salud.madrid.org
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Maria Eugenia Olmedo, maruolmedogarcia@hotmail.com
- Recruiting
Hospital Virgen de la Victoria
Málaga, Andalusia
Laura Medina, laura.medina.eecc@gmail.com
- Recruiting
Hospital Clínico Universitario Virgen de la Arrizaca
Murcia
Silverio Ros, silveriorosmartinez@gmail.com
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Marta López- Brea, marta.lopezbrea@gmail.com
- Recruiting
Hospital Virgen del Rocio
Seville, Andalusia
Reyes Bernabé, reyesbernab@yahoo.es
- Recruiting
Hospital Universitario Virgen Macarena
Seville
David Vicente, dvicentebaz@yahoo.es
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Dolores Isla, lola.isla@gmail.com
About this study
Official title: Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients With Advanced Small Cell Lung Cancer That Progressed Following Prior Therapy With Platinum-Based Chemotherapy.
Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. The study will be divided into two parts: a dose-ranging phase I with escalating doses of PM01183 in combination with a fixed dose of atezolizumab, followed by a single-arm phase II part with expansion at the RD determined during the phase I.
Read the detailed description
Phase I Patients will receive atezolizumab at a fixed dose of 1200 mg intravenously (i.v.) followed by PM01183 at a starting dose of 2.5 mg/m2 i.v. as a 1-hour infusion on Day 1 every three weeks (q3wk). PM01183 doses will be escalated in successive cohorts of patients following a modified Fibonacci scheme and a classical 3+3 design, and according to observed tolerance and safety.
Phase II Patients will receive atezolizumab i.v. as a 60-minute infusion (the second and subsequent infusions may be administered over 30 minutes) followed by PM01183 i.v. as a 1-hour infusion on Day 1 q3wk, at the RD determined during the phase I part.
It is expected that approximately 50% of patients included were previously treated with chemotherapy and the other 50% with immunotherapy and chemotherapy. In case one of the groups reaches 50% of the total number of patients expected to be recruited, no further patient will be included in this group and accrual will be limited to patients with the other group.
It is expected that approximately 50% of the patients included in the phase II part will be platinum-resistant [i.e., chemotherapy-free interval (CTFI) 30 to < 90 days from the end of first-line platinum-based chemotherapy] and 50% will be platinum-sensitive (i.e., CTFI ≥ 90 days), so as to assess efficacy in both settings. However in case that one of the CTFI groups reaches 60% of the total number of patients expected to be recruited, no further patient will be included in this group and accrual will be limited to patients with the other CTFI group.
- Conditions
- Carcinoma, Small Cell Lung
- Being tested
- PM 01183, Atezolizumab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM 01183Drug
Also called Lurbinectidin
Lyophilisate for solution for infusion
AtezolizumabDrug
Also called Tecentriq
Concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| PM01183 w/ Atezolizumab | Experimental | Patients will receive atezolizumab at a fixed dose of 1200 mg intravenously (i.v.) as a 60-minute infusion (the second and subsequent infusions may be administered over 30 minutes) followed by PM01183 at a starting dose of 2.5 mg/m2 i.v. as a 1-hour infusion on Day 1 every three weeks (q3wk). Following analysis of cohorts, dose levels can be escalated from 2.5mg to 3.2, to a maximum dose of 3.5 mg of PM01183 Receives: Drug: PM 01183; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerable Dose
The MTD will be the lowest dose level explored during dose escalation at which more than one third of evaluable patients experience a DLT during Cycle 1.
Measured: one cycle - 21 days
Determination Recomended Dose:
The RD will be the highest dose level explored during dose escalation at which less than one third of evaluable patients experience a DLT during Cycle 1.
Measured: one cycle - 21 days
Secondary outcomes (11)
Progression-free survival
the time from the date of registration to the date of documented progression per RECIST v.1.1 or death. If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Measured: the time from the date of registration to the date of documented progression per RECIST v.1.1 or death, assessed approximately up to 30 months
Duration of response
Duration of response will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever comes first) to the date of documented PD or death. The censoring rules defined above for PFS will be used for DoR.
Measured: from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever comes first) to the date of documented PD or death, assessed approximately up to 30 months
Clinical benefit
defined as percentage of evaluable patient with complete response, partial response or stable disease lasting ≥3 months, as defined by RECIST v1.1.
Measured: ≥3 months
Overall survival
calculated from the date of registration to the date of death (death event) or last contact (in this case, survival will be censored on that date).
Measured: from the date of registration to the date of death or last contact; approximately 30 months
Mid- and long-term survival
will be the Kaplan-Meier estimates of the probability of being alive at these time points
Measured: 12, 18 and 24 months
Pharmacokinetics measures - plasma concentration
PK parameters will be evaluated in plasma by standard non-compartmental methods (compartmental modeling may be performed if appropriate).The dose-exposure relationships for maximum plasma concentration (Cmax) and any potential PK interaction of atezolizumab over PM01183 will be explored.
Measured: 8 days
Pharmacogenetics measurements of genes implicated in the metabolism and/or transport of PM01183
In order to explore factors that may help explain individual variability in the main PK parameters, the presence or absence of germline mutations or polymorphisms in genes that may be involved in the metabolism and/or transport of PM01183 will be analyzed in leukocyte DNA extracted from one blood sample (10 mL) obtained at any time during the study, but preferably just before treatment start in Cycle 1 along with the first PK sample
Measured: 1 day
Pharmacogenomics measurements of predictive/prognostic markers of response and/or resistance to PM01183 and atezolizumab
In order to determine predictive/prognostic markers of response and/or resistance to PM01183 and atezolizumab, tumor samples available at baseline and blood samples (Day 1 of every cycle and end-of-treatment) wil be evaluated in all patients. In addition, on- treatment tumor samples from biopsy (4ht to 6ht weeks after treatment onset) wil be obtained and evaluated for patients cosenting to PGx sub- study.
Measured: 1 day
Pharmacogenomics measures sub-study - tumor samples
For tumor biomarkers research, tumor samples will be collected on-treatment to be analyzed at the end of the study. The on-treatment biopsy will be optional, requiring specific patient consent.
The on-treatment tumor samples will be compared to baseline tumor samples and the biomarker to analize are:
PD-L1 and PD-L2 expression in tumor cells and in tumor-infiltrating immune cells, presence of CD8+ T cell and CD4+ T cell in stromal-tumor edge and inside the tumor parenchyma, tumor-infiltrating lymphocyte (TIL) density, expression of granzyme B, the activated transcription factor signal transducer and activator of transcription 1 (pSTAT1), Ki67, interferon gamma (IFNƔ), tumor necrosis factor alpha (TNF-α), cytotoxic T-lymphocyte-associated protein 4 (CTLA4), fractalkine, lymphocyte-activation gene 3 (LAG-3) and T-cell immunoglobulin and mucin protein 3 (TIM-3) by IHC;
and Tumor mutational burden by DNAseq with Foundation One (or another similar validated panel).
Measured: one sample between 4th to 6th weeks after treatment onset
Pharmacokinetics measures - area under the curve
PK parameters will be evaluated in plasma by standard non-compartmental methods (compartmental modeling may be performed if appropriate).The area under the curve (AUC) will be evaluated, and any potential PK interaction of atezolizumab over PM01183 will be explored.
Measured: 8 days
Pharmacogenomics measures sub-study - blood samples
For those patients specifically consenting, blood samples for the evaluation of biomarkers will be drawn just before treatment on Day 1 of each cycle and at EOT.
The biomarker to analize are:
- Plasma cytokine analysis by enzyme-linked immunosorbent assay (ELISA): IFNƔ, TNF-α, interleukins IL-1β, IL-6 and IL-18, and CXCL11 (ITAC).
Measured: First day of each cycle (each cycle is 21 days) and at the End of Treatment visit, which is up to 37 days after the last study treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Dec 2019
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small Cell LungStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, uncontrolled and multicenter phase I-II study
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Oncosur
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Santiago Ponce, MD, Principal investigator, Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253145
- Sponsor's protocol ID
- 2SMALL
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients With Advanced Small Cell Lung Cancer That Progressed Following Prior Therapy With Platinum-Based Chemotherapy.
- ClinicalTrials.gov ID
- NCT04253145
- Acronym / sponsor ID
- 2SMALL
- Conditions
- Carcinoma, Small Cell Lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Fundacion OncosurResearch network
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Feb 2020 (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.
Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. The study will be divided into two parts: a dose-ranging phase I with escalating doses of PM01183 in combination with a fixed dose of atezolizumab, followed by a single-arm phase II part with expansion at the RD determined during the phase I.
Detailed description
Phase I Patients will receive atezolizumab at a fixed dose of 1200 mg intravenously (i.v.) followed by PM01183 at a starting dose of 2.5 mg/m2 i.v. as a 1-hour infusion on Day 1 every three weeks (q3wk). PM01183 doses will be escalated in successive cohorts of patients following a modified Fibonacci scheme and a classical 3+3 design, and according to observed tolerance and safety.
Phase II Patients will receive atezolizumab i.v. as a 60-minute infusion (the second and subsequent infusions may be administered over 30 minutes) followed by PM01183 i.v. as a 1-hour infusion on Day 1 q3wk, at the RD determined during the phase I part.
It is expected that approximately 50% of patients included were previously treated with chemotherapy and the other 50% with immunotherapy and chemotherapy. In case one of the groups reaches 50% of the total number of patients expected to be recruited, no further patient will be included in this group and accrual will be limited to patients with the other group.
It is expected that approximately 50% of the patients included in the phase II part will be platinum-resistant [i.e., chemotherapy-free interval (CTFI) 30 to < 90 days from the end of first-line platinum-based chemotherapy] and 50% will be platinum-sensitive (i.e., CTFI ≥ 90 days), so as to assess efficacy in both settings. However in case that one of the CTFI groups reaches 60% of the total number of patients expected to be recruited, no further patient will be included in this group and accrual will be limited to patients with the other CTFI group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, uncontrolled and multicenter phase I-II study
| Arm | Type | Receives |
|---|---|---|
| PM01183 w/ Atezolizumab | Experimental | Drug: PM 01183, Drug: AtezolizumabPatients will receive atezolizumab at a fixed dose of 1200 mg intravenously (i.v.) as a 60-minute infusion (the second and subsequent infusions may be administered over 30 minutes) followed by PM01183 at a starting dose of 2.5 mg/m2 i.v. as a 1-hour infusion on Day 1 every three weeks (q3wk). Following analysis of cohorts, dose levels can be escalated from 2.5mg to 3.2, to a maximum dose of 3.5 mg of PM01183 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntarily signed and dated written informed consent prior to any specific study procedure.
- Age >18 years.
- Histologically or cytologically confirmed diagnosis of extensive or limited SCLC.
- Progression to first-line platinum-based chemotherapy. For phase II part: Progression to first- line platinum-based chemotherapy or first- line platinum- based chemotherapy and immunoterapy (anti PD1/ PDL1). A chemotherapy and/ or immunotherapy- free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤1.
Key exclusion criteria (26 listed)
- Active or untreated central nervous system (CNS) involvement. Treated CNS metastases have to show radiographic stability (defined as no CNS progression for at least three weeks from post-radiotherapy brain scan to brain scan performed prior study entry), and patients should not have neurologic sign/symptoms secondary to the brain metastases or RT. Any steroid treatment must be completed ≥ 14 days before first dose of study treatment.
- More than one prior chemotherapy-containing line (re-challenge with the same initial regimen is not allowed).
- Patients with radiation therapy (RT) in more than 35% of the bone marrow.
- History of previous bone marrow and/or stem cell transplantation.
- Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
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 |
|---|---|---|
| PM 01183Also: LurbinectidinLyophilisate for solution for infusion | Drug | PM01183 w/ Atezolizumab |
| AtezolizumabAlso: TecentriqConcentrate for solution for infusion | Drug | PM01183 w/ Atezolizumab |
Primary outcome
Determination of Maximum Tolerable Dose
Time frame: one cycle - 21 days
The MTD will be the lowest dose level explored during dose escalation at which more than one third of evaluable patients experience a DLT during Cycle 1.
Determination Recomended Dose:
Time frame: one cycle - 21 days
The RD will be the highest dose level explored during dose escalation at which less than one third of evaluable patients experience a DLT during Cycle 1.
11 secondary outcomes
Progression-free survival
Time frame: the time from the date of registration to the date of documented progression per RECIST v.1.1 or death, assessed approximately up to 30 months
Duration of response
Time frame: from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever comes first) to the date of documented PD or death, assessed approximately up to 30 months
Clinical benefit
Time frame: ≥3 months
Overall survival
Time frame: from the date of registration to the date of death or last contact; approximately 30 months
Mid- and long-term survival
Time frame: 12, 18 and 24 months
Pharmacokinetics measures - plasma concentration
Time frame: 8 days
Pharmacogenetics measurements of genes implicated in the metabolism and/or transport of PM01183
Time frame: 1 day
Pharmacogenomics measurements of predictive/prognostic markers of response and/or resistance to PM01183 and atezolizumab
Time frame: 1 day
Pharmacogenomics measures sub-study - tumor samples
Time frame: one sample between 4th to 6th weeks after treatment onset
Pharmacokinetics measures - area under the curve
Time frame: 8 days
Pharmacogenomics measures sub-study - blood samples
Time frame: First day of each cycle (each cycle is 21 days) and at the End of Treatment visit, which is up to 37 days after the last study treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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. This study is not recruiting at the moment.
Santiago Ponce, MD principal investigator
Hospital 12 de Octubre
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PM 01183 and Atezolizumab in people with Carcinoma, Small Cell Lung, run by Fundacion Oncosur at 13 sites in Spain.
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 18 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Paz Ares, MD PhD (+ 34 91 390 8000, lpazaresr@seom.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Maximum Tolerable Dose (time frame: one cycle - 21 days). The study lists 2 primary outcomes in all. 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 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.