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JOURNAL ONKOLOGIE – STUDIE
POSEIDON

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Rekrutierend

NCT-Nummer:
NCT03164616

Studienbeginn:
Juni 2017

Letztes Update:
26.03.2021

Wirkstoff:
Durvalumab, Abraxane + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + carboplatin, Pemetrexed + cisplatin, Tremelimumab

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Norah Shire, M.D., Ph.D.
Study Director
One MedImmune Way, Gaithersburg, Maryland 20878, United States

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen
AstraZeneca Cancer Study Locator Service
Kontakt:
Phone: 1-877-400-4656
E-Mail: AstraZeneca@emergingmed.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 185)

Research Site
13125 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
45122 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
79106 Freiburg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
82131 Gauting
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
21075 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
34376 Immenhausen
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
55131 Mainz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
97067 Würzburg
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
93309 Bakersfield
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
33901 Fort Myers
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
33705 Saint Petersburg
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
33401 West Palm Beach
United StatesAbgeschlossen» Google-Maps
Research Site
40202 Louisville
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
15212 Pittsburgh
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
77090 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
14784-400 Barretos
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
30380-472 Belo Horizonte
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
90035-003 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
90610-000 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
91350-200 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
14015-140 Ribeirao Preto
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
20231-050 Rio de Janeiro
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
01246-000 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
15090-000 São José do Rio Preto
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
03102-002 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
2045 Törökbálint
HungaryAktiv, nicht rekrutierend» Google-Maps
Research Site
113-8603 Bunkyo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
812-8582 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
730-0011 Hiroshima-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
740-8510 Iwakuni-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
830-0011 Kurume-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
790-0007 Matsuyama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
700-8607 Okayama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
411-8777 Sunto-gun
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
236-0004 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
241-8515 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
47392 Busan
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
28644 Chungcheongbuk-do
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
42415 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
21565 Incheon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
13620 Seongnam-si
Korea, Republic ofAbgeschlossen» Google-Maps
Research Site
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
06591 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
120-752 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
135-710 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
20230 Aguascalientes
MexicoAktiv, nicht rekrutierend» Google-Maps
Research Site
62508 Cuernavaca
MexicoAktiv, nicht rekrutierend» Google-Maps
Research Site
44280 Guadalajara
MexicoAktiv, nicht rekrutierend» Google-Maps
Research Site
AREQUIPA01 Arequipa
PeruAktiv, nicht rekrutierend» Google-Maps
Research Site
44-300 Wodzisław Śląski
PolandAktiv, nicht rekrutierend» Google-Maps
Research Site
105229 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Research Site
115280 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Research Site
115478 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Research Site
644013 Omsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Research Site
195271 Saint Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Research Site
194291 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
197758 St. Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Research Site
0001 Johannesburg
South AfricaAktiv, nicht rekrutierend» Google-Maps
Research Site
2193 Johannesburg
South AfricaAktiv, nicht rekrutierend» Google-Maps
Research Site
7570 Kraaifontein
South AfricaAktiv, nicht rekrutierend» Google-Maps
Research Site
0001 Pretoria
South AfricaAktiv, nicht rekrutierend» Google-Maps
Research Site
7700 Rondebosch
South AfricaAktiv, nicht rekrutierend» Google-Maps
Research Site
1930 Vereeniging
South AfricaAktiv, nicht rekrutierend» Google-Maps
Research Site
50006 Changhua City
TaiwanAktiv, nicht rekrutierend» Google-Maps
Research Site
83301 Kaohsiung City
TaiwanAktiv, nicht rekrutierend» Google-Maps
Research Site
25006 Kirovohrad
UkraineAktiv, nicht rekrutierend» Google-Maps
Research Site
21029 Vinnytsia
UkraineAktiv, nicht rekrutierend» Google-Maps
Research Site
69040 Zaporizhzhia
UkraineAktiv, nicht rekrutierend» Google-Maps
Research Site
LE1 5WW Leicester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
EC1M 6BQ London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
NW1 2PG London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
W6 8RF London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
M20 4BX Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
700000 Ho Chi Minh
VietnamAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Adult patients with a histologically or cytologically documented metastatic NSCLC, with

tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment.

Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab +

tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC

chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until

objective disease progression as efficacy assessment. All patients will be followed for

survival until the end of the study. An independent data monitoring committee (IDMC) composed

of independent experts will be convened to confirm the safety and tolerability of the

proposed dose and schedule.

Ein-/Ausschlusskriterien

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Aged at least 18 years.

2. Histologically or cytologically documented Stage IV NSCLC.

3. Confirmed tumor PD-L1 status prior to randomization.

4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.

5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.

6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance

status of 0 or 1.

7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer

vaccines.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are

fulfilled:

1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.

2. Active or prior documented autoimmune or inflammatory disorders.

3. Brain metastases or spinal cord compression unless the patient's condition is stable

and off steroids.

4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human

immunodeficiency virus.

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 (Time Frame - Up to 3 years after first patient randomized)

2. Overall Survival (OS) (Time Frame - Up to 4 years after first patient randomized)

Secondary outcome:

1. Progression-free survival (PFS) using BICR assessments according to RECIST 1.1 (Time Frame - Up to 3 years after first patient randomized)

2. Overall survival (OS) (Time Frame - Up to 4 years after first patient randomized)

3. Objective response rate (ORR) using BICR assessments according to RECIST 1.1 (Time Frame - Up to 3 years after first patient randomized)

4. Duration of response (DoR) using BICR assessments according to RECIST 1.1 (Time Frame - Up to 3 years after first patient randomized)

5. Time from randomization to second progression (PFS2) (Time Frame - Up to 3 years after first patient randomized)

6. Proportion of patients alive and progression free at 12 months from randomization (APF12) using BICR assessments according to RECIST 1.1 (Time Frame - Up to 12 months)

7. Best objective response (BoR) using BICR assessments according to RECIST 1.1 (Time Frame - Up to 3 years after first patient randomized)

8. The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by concentration (Time Frame - Up to 3 years after first patient randomized)

9. The immunogenicity of durvalumab and tremelimumab as assessed by presence of anti-drug antibodies (ADAs) (Time Frame - Up to 3 years after first patient randomized)

10. Health-related QoL measured by EORTC QLQ-C30 v3 (Time Frame - Up to 3 years after first patient randomized)

11. Disease-related symptoms measured by EORTC QLQ-LC13 (Time Frame - Up to 3 years after first patient randomized)

12. Changes in WHO/ECOG performance status (Time Frame - Up to 3 years after first patient randomized)

Studien-Arme

  • Experimental: Treatment Arm 1
    durvalumab + tremelimumab combination therapy + SoC chemotherapy
  • Experimental: Treatment Arm 2
    durvalumab monotherapy + SoC chemotherapy
  • Active Comparator: Treatment Arm 3
    SoC chemotherapy alone

Geprüfte Regime

  • Durvalumab:
    IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria
  • Tremelimumab:
    IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.
  • Abraxane + carboplatin:
    Standard of care chemotherapy (squamous and non-squamous patients)
  • Gemcitabine + cisplatin:
    Standard of care chemotherapy (squamous patients only)
  • Gemcitabine + carboplatin:
    Standard of care chemotherapy (squamous patients only)
  • Pemetrexed + carboplatin:
    Standard of care chemotherapy (non-squamous patients only)
  • Pemetrexed + cisplatin:
    Standard of care chemotherapy (non-squamous patients only)

Quelle: ClinicalTrials.gov


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